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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01672892
Other study ID # RTOG-1203
Secondary ID CDR0000738944NCI
Status Completed
Phase Phase 3
First received
Last updated
Start date November 2012
Est. completion date May 20, 2022

Study information

Verified date May 2022
Source Radiation Therapy Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This randomized phase III trial is studying two different methods of radiation and their side effects and comparing how well they work in treating endometrial and cervical cancer after surgery.


Description:

OBJECTIVES: Primary - To determine if pelvic intensity-modulated radiation therapy (IMRT) reduces acute gastrointestinal toxicity in the 5th week (after 23-25 fractions) of pelvic radiation as measured with the expanded prostate cancer index composite (EPIC) instrument. Secondary - To determine if grade 2+ gastrointestinal toxicity (Common Terminology Criteria for Adverse Events version 4.0 [CTCAE v. 4.0]) is reduced with IMRT compared to conventional whole-pelvis radiation therapy (WPRT). - To determine if grade 2+ hematologic toxicity (CTCAE v. 4.0) is reduced with IMRT compared to conventional WPRT. - To determine if urinary toxicity is reduced with IMRT using the EPIC urinary domain. - To validate EPIC bowel and urinary domains in women undergoing either IMRT pelvic radiation treatment or four-field pelvic radiation treatment for endometrial or cervical cancer. - To assess the impact of pelvic IMRT on quality of life using the Functional Assessment of Cancer Therapy-General (FACT-G) with cervix subscale. - To determine if there is any difference in local-regional control, disease-free survival, and overall survival between patients treated with IMRT as compared to conventional WPRT. - To perform a health-utilities analysis to measure the financial impact of pelvic IMRT via the EQ-5D instrument. - To identify molecular predictors of radiation toxicity and novel circulating cancer biomarkers. OUTLINE: This is a multicenter study. Patients are stratified according to type of cancer (endometrial vs cervical), chemotherapy (none vs 5 courses of weekly cisplatin at 40 mg/m²), and radiation dose (45 Gy vs 50.4 Gy). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo standard (3-dimensional) radiation therapy 5 days a week for up to 5-6 weeks. - Arm II: Patients undergo intensity-modulated radiation therapy (IMRT) 5 days a week for up to 5-6 weeks. Some patients receive cisplatin IV over 1 hour on day 1. Treatment continues weekly for 5 weeks, concurrently with radiation therapy, in the absence of unacceptable toxicity or disease progression. Tissue and blood samples may be collected for biomarker and correlative analysis. Quality of life may be assessed by questionnaires (including the Expanded Prostate Cancer Index Composite [EPIC], the Functional Assessment of Cancer Therapy-General [FACT-G, Version 4], the EQ-5D, and the Common Toxicity Criteria Adverse Events - Patient-Reported Outcome [PRO-CTCAE]) instruments at baseline and periodically during and after study therapy. After completion of study therapy, patients are followed every 6 months for the first 2 years and then annually for 5 years.


Recruitment information / eligibility

Status Completed
Enrollment 289
Est. completion date May 20, 2022
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion criteria: 1. Pathologically proven diagnosis of endometrial or cervical cancer. 2. Patients must have undergone a hysterectomy (total abdominal hysterectomy, vaginal hysterectomy or radical hysterectomy or total laparoscopic hysterectomy) for carcinoma of the cervix or endometrium within 49 days prior to registration. Performance of a bilateral salpingooophorectomy will be at the treating surgeon's discretion. 3. Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup: - 3.1 History/physical examination within 45 days prior to registration; - 3.2 CT, MRI or positron emission tomography - computed tomography (PET-CT) including the abdomen and pelvis should be performed for initial radiological staging. This may be performed pre- or post-surgery within 90 days prior to registration. Imaging performed post-operatively should show no evidence of residual disease. Any evidence of malignancy identified on pre-operative imaging should have been completely resected surgically prior to protocol treatment. - 3.3 Chest CT or chest x-ray must be performed within 90 days prior to registration (unless a PET-CT has been performed) 4. Zubrod Performance Status 0-2 5. Age = 18; 6. Complete blood count (CBC)/differential obtained within 14 days prior to registration on study, with adequate bone marrow function defined as follows: - 6.1 Absolute neutrophil count (ANC) = 1,500 cells/mm3; - 6.2 Platelets = 100,000 cells/mm3; - 6.3 Hemoglobin = 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb = 8.0 g/dl is acceptable.) 7. For patients receiving chemotherapy: 7.1 Within 14 days prior to registration, serum creatinine = 1.5 mg/dL and calculated creatinine clearance = 50 cc/min. Both tests must be within these limits. The creatinine clearance should be calculated using the Cockcroft-Gault formula: (See Section 7.3.1) 7.2 Aspartate aminotransferase (AST) = 2 x upper limit of normal (ULN) 7.3 Bilirubin = 2 x ULN 7.4 Alkaline phosphatase, Mg, blood urea nitrogen (BUN) and electrolytes must be obtained and recorded 8 Endometrial Cancer: 8.1 Patients with the following histologic features are eligible for pelvic radiation therapy without weekly cisplatin: - <50% myometrial invasion, grade 3 adenocarcinoma without uterine serous carcinoma (USC) or clear cell histology - =50% myometrial invasion grade 1-2 adenocarcinoma without USC or clear cell histology 8.2 Patients with the following histologic features may be treated with pelvic radiation with or without weekly cisplatin. The decision to add weekly cisplatin for these patients is at the treating physician's discretion: - =50% myometrial invasion, grade 3 including USC and clear cell carcinoma. - International Federation of Gynecology and Obstetrics (FIGO) 2009 stage II endometrial cancer of any grade including USC and clear cell carcinoma. - FIGO 2009 IIIC1 (pelvic lymph node positive only, para-aortic nodes negative if removed) including USC and clear cell carcinoma. Note: If para-aortic nodes are not removed, CT abdomen or PET CT must demonstrate no evidence of lymphadenopathy. 9. Cervical Cancer: 9.1 Patients with the following pathology findings may be treated with pelvic radiation with or without weekly cisplatin at the treating physician's discretion. The decision to add weekly cisplatin for these patients is at the treating physician's discretion. 9.1.1 Patients with intermediate risk features including two of the following histologic findings after radical hysterectomy: - 1/3 or more stromal invasion - Lymph-vascular space invasion - Large clinical tumor diameter (> 4 cm) 9.1.2 Patients with cervical cancer treated with a simple hysterectomy with negative margins 9.2 Patients with any of the following criteria following radical hysterectomy are eligible for this study and must receive weekly cisplatin: - Positive resected pelvic nodes and para-aortic nodes negative if removed. Note: If para-aortic nodes are not removed, CT abdomen or PET CT must demonstrate no evidence of lymphadenopathy. - Microscopic parametrial invasion with negative margins. 10. Patient must provide study specific informed consent prior to study entry. 11. Willingness and ability to complete the bowel and urinary domains of the EPIC prior to registration Exclusion criteria: 1. Patients with para-aortic nodal disease or who require extended field radiotherapy beyond the pelvis. 2. Patients with histology consisting of endometrial stromal sarcoma, leiomyosarcoma or malignant mixed mullerian mixed tumor (MMMT or carcinosarcoma) 3. Patients who exceed the weight/size limits of the treatment table or CT scanner. 4. Mental status changes or bladder control problems that make the patient unable to comply with bladder-filling instructions. 5. Patients with evidence of metastatic disease outside of the pelvis. 6. Patients with positive or close (< 3 mm) resection margins 7. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years. 8. Prior radiation therapy to the pelvis 9. Patients with active inflammatory bowel disease. 10 Severe, active co-morbidity, defined as follows: - 10.1 Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months - 10.2 Transmural myocardial infarction within the last 6 months - 10.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration - 10.4 Other major medical illness which requires hospitalization or precludes study therapy at the time of registration - 10.5 Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however,that laboratory test coagulation parameters are not required for entry into this protocol - 10.6 Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immunocompromised patients. 11. Patients with prior treatment with platinum-based chemotherapy 12. Women who are breastfeeding

Study Design


Intervention

Radiation:
Standard radiation therapy
Patients treated once a day, 5 days a week with a daily fraction size of 1.8 Gy. Whole pelvis treated with a four-field technique (AP/PA/R lateral/L lateral) to 45 or 50.4 Gy at 1.8 Gy/fraction. The dose is prescribed to the isocenter which is defined as the intersection of the four beams and can be normalized to an isodose line between 97-100%. The decision to deliver 45 or 50.4 Gy is at the physician's discretion and must be reported at the time of enrollment.
intensity-modulated radiation therapy
Patients treated once a day, 5 days a week with a daily fraction size of 1.8 Gy. All targets treated simultaneously. The vaginal planning target volume (PTV) (ITV with 7.0 mm margin) and nodal PTV receives 45 Gy in 25 fractions or 50.4 Gy in 28 fractions. The decision to deliver 45 or 50.4 Gy is at the physician's discretion and must be reported at the time of enrollment.

Locations

Country Name City State
Canada Juravinski Cancer Centre at Hamilton Health Sciences Hamilton Ontario
Canada BCCA-Cancer Centre for the Southern Interior Kelowna British Columbia
Canada London Regional Cancer Program London Ontario
Canada Allan Blair Cancer Centre Regina Saskatchewan
Canada Saskatoon Cancer Centre Saskatoon Saskatchewan
Canada BCCA-Vancouver Island Cancer Centre Victoria British Columbia
Hong Kong Pamela Youde Nethersole Eastern Hospital Chai Wan
Singapore National University Hospital Singapore
United States Leeward Radiation Oncology Center 'Ewa Beach Hawaii
United States Abington Memorial Hospital Abington Pennsylvania
United States Summa Akron City Hospital/Cooper Cancer Center Akron Ohio
United States University of New Mexico Albuquerque New Mexico
United States McFarland Clinic PC-William R Bliss Cancer Center Ames Iowa
United States Saint Vincent Anderson Regional Hospital/Cancer Center Anderson Indiana
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States Emory University/Winship Cancer Institute Atlanta Georgia
United States Grady Health System Atlanta Georgia
United States Northside Hospital Atlanta Georgia
United States Piedmont Hospital Atlanta Georgia
United States University of Colorado Cancer Center - Anschutz Cancer Pavilion Aurora Colorado
United States Greater Baltimore Medical Center Baltimore Maryland
United States Sinai Hospital of Baltimore Baltimore Maryland
United States Summa Barberton Hospital Barberton Ohio
United States Mary Bird Perkins Cancer Center Baton Rouge Louisiana
United States Sanford Clinic North-Bemidgi Bemidji Minnesota
United States Billings Clinic Billings Montana
United States Sanford Bismarck Medical Center Bismarck North Dakota
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States Boston Medical Center Boston Massachusetts
United States Brigham and Women's Hospital Boston Massachusetts
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Geaugra Hospital Chardon Ohio
United States Medical University of South Carolina Charleston South Carolina
United States Advocate Illinois Masonic Medical Center Chicago Illinois
United States John H Stroger Jr Hospital of Cook County Chicago Illinois
United States Northwestern University Chicago Illinois
United States University of Illinois Chicago Illinois
United States Case Western Reserve University Cleveland Ohio
United States Mercy Cancer Center-West Lakes Clive Iowa
United States Penrose-Saint Francis Healthcare Colorado Springs Colorado
United States The Mark H Zangmeister Center Columbus Ohio
United States Northside Hospital-Forsyth Cumming Georgia
United States University of Texas Southwestern Medical Center Dallas Texas
United States Porter Adventist Hospital Denver Colorado
United States Iowa Methodist Medical Center Des Moines Iowa
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Saint John Hospital and Medical Center Detroit Michigan
United States Wayne State University/Karmanos Cancer Institute Detroit Michigan
United States Franciscan Saint Margaret Health-Dyer Campus Dyer Indiana
United States Swedish Medical Center Englewood Colorado
United States Saint Francis Hospital Federal Way Washington
United States Radiation Oncology Associates PC Fort Wayne Indiana
United States California Cancer Center - North Fresno Fresno California
United States Northeast Georgia Medical Center Gainesville Georgia
United States University of Florida Gainesville Florida
United States Banner MD Anderson Cancer Center Gilbert Arizona
United States Mercy Health Saint Mary's Grand Rapids Michigan
United States Spectrum Health at Butterworth Campus Grand Rapids Michigan
United States Aurora BayCare Medical Center Green Bay Wisconsin
United States Self Regional Healthcare Greenwood South Carolina
United States Franciscan Saint Margaret Health-Hammond Campus Hammond Indiana
United States Ingalls Memorial Hospital Harvey Illinois
United States Queen's Medical Center Honolulu Hawaii
United States The Cancer Center of Hawaii-Liliha Honolulu Hawaii
United States University of Hawaii Honolulu Hawaii
United States M D Anderson Cancer Center Houston Texas
United States Edwards Comprehensive Cancer Center Huntington West Virginia
United States University of Florida Health Science Center Jacksonville Florida
United States UC San Diego Moores Cancer Center La Jolla California
United States Rocky Mountain Cancer Centers-Littleton Littleton Colorado
United States Logan Regional Hospital Logan Utah
United States Longmont United Hospital Longmont Colorado
United States McKee Medical Center Loveland Colorado
United States Lowell General Hospital Lowell Massachusetts
United States Summa Health Center at Lake Medina Medina Ohio
United States Lake University Ireland Cancer Center Mentor Ohio
United States Jackson Memorial Hospital-Holtz Children's Hospital Miami Florida
United States University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida
United States Southwest General Health Center Ireland Cancer Center Middleburg Heights Ohio
United States Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Milford Massachusetts
United States Aurora Saint Luke's Medical Center Milwaukee Wisconsin
United States Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County Mount Holly New Jersey
United States Intermountain Medical Center Murray Utah
United States Long Island Jewish Medical Center New Hyde Park New York
United States North Shore-LIJ Health System/Center for Advanced Medicine New Hyde Park New York
United States Ochsner Medical Center Jefferson New Orleans Louisiana
United States Christiana Care Health System-Christiana Hospital Newark Delaware
United States Kaiser Permanente Oakland-Broadway Oakland California
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States The Nebraska Medical Center Omaha Nebraska
United States Saint Joseph Hospital - Orange Orange California
United States UHHS-Chagrin Highlands Medical Center Orange Village Ohio
United States Paoli Memorial Hospital Paoli Pennsylvania
United States Feather River Cancer Center Paradise California
United States Capital Health Medical Center-Hopewell Pennington New Jersey
United States Radiation Therapy Oncology Group Philadelphia Pennsylvania
United States Arizona Oncology-Deer Valley Center Phoenix Arizona
United States Pomona Valley Hospital Medical Center Pomona California
United States Southern Ohio Medical Center Portsmouth Ohio
United States Kaiser Permanente-Rancho Cordova Cancer Center Rancho Cordova California
United States Rapid City Regional Hospital Rapid City South Dakota
United States Beebe Health Campus Rehoboth Beach Delaware
United States Rohnert Park Cancer Center Rohnert Park California
United States The Permanente Medical Group-Roseville Radiation Oncology Roseville California
United States South Sacramento Cancer Center Sacramento California
United States University of California at Davis Cancer Center Sacramento California
United States Dixie Medical Center Regional Cancer Center Saint George Utah
United States Saint John's Mercy Medical Center Saint Louis Missouri
United States United Hospital Saint Paul Minnesota
United States Peninsula Regional Medical Center Salisbury Maryland
United States Huntsman Cancer Institute/University of Utah Salt Lake City Utah
United States LDS Hospital Salt Lake City Utah
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States Kaiser Permanente Medical Center - Santa Clara Santa Clara California
United States Saint Joseph's-Candler Health System Savannah Georgia
United States Arizona Oncology Services Foundation Scottsdale Arizona
United States Virginia Mason CCOP Seattle Washington
United States Holy Cross Hospital Silver Spring Maryland
United States Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota
United States Kaiser Permanente Cancer Treatment Center South San Francisco California
United States Dana-Farber/Brigham and Women's Cancer Center at South Shore South Weymouth Massachusetts
United States CoxHealth South Hospital Springfield Missouri
United States D'Amour Center for Cancer Care Springfield Massachusetts
United States Mercy Hospital Springfield Springfield Missouri
United States Mount Nittany Medical Center State College Pennsylvania
United States Stony Brook University Medical Center Stony Brook New York
United States South Atlantic Radiation Oncology Supply North Carolina
United States Virtua West Jersey Hospital Voorhees Voorhees New Jersey
United States Ridgeview Medical Center Waconia Minnesota
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States Washington Hospital Center Washington District of Columbia
United States Aurora West Allis Medical Center West Allis Wisconsin
United States Reading Hospital West Reading Pennsylvania
United States UHHS-Westlake Medical Center Westlake Ohio
United States Coastal Carolina Radiation Oncology Wilmington North Carolina
United States New Hanover Regional Medical Center Wilmington North Carolina
United States Lankenau Hospital Wynnewood Pennsylvania

Sponsors (3)

Lead Sponsor Collaborator
Radiation Therapy Oncology Group National Cancer Institute (NCI), NRG Oncology

Countries where clinical trial is conducted

United States,  Canada,  Hong Kong,  Singapore, 

References & Publications (3)

Gil KM, Pugh SL, Klopp AH, Yeung AR, Wenzel L, Westin SN, Gaffney DK, Small W Jr, Thompson S, Doncals DE, Cantuaria GHC, Yaremko BP, Chang A, Kundapur V, Mohan DS, Haas ML, Kim YB, Ferguson CL, Deshmukh S, Kachnic LA, Bruner DW. Expanded validation of the — View Citation

Klopp AH, Yeung AR, Deshmukh S, Gil KM, Wenzel L, Westin SN, Gifford K, Gaffney DK, Small W Jr, Thompson S, Doncals DE, Cantuaria GHC, Yaremko BP, Chang A, Kundapur V, Mohan DS, Haas ML, Kim YB, Ferguson CL, Pugh SL, Kachnic LA, Bruner DW. Patient-Reporte — View Citation

Yeung AR, Pugh SL, Klopp AH, Gil KM, Wenzel L, Westin SN, Gaffney DK, Small W Jr, Thompson S, Doncals DE, Cantuaria GHC, Yaremko BP, Chang A, Kundapur V, Mohan DS, Haas ML, Kim YB, Ferguson CL, Deshmukh S, Bruner DW, Kachnic LA. Improvement in Patient-Reported Outcomes With Intensity-Modulated Radiotherapy (RT) Compared With Standard RT: A Report From the NRG Oncology RTOG 1203 Study. J Clin Oncol. 2020 May 20;38(15):1685-1692. doi: 10.1200/JCO.19.02381. Epub 2020 Feb 19. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Acute Gastrointestinal Toxicity, as Measured by Change in Expanded Prostate Cancer Index Composite (EPIC) Bowel Domain Score at 5 Weeks From the Start of Pelvic Radiation The primary endpoint is change in acute GI toxicity, as measured by the EPIC bowel domain, from baseline to 5 weeks after the first fraction of radiation is delivered. The EPIC has four domains (bowel, urinary, sexual, and hormonal) that have been validated separately, which allows use of only the domains of interest. The EPIC bowel domain consists of 14 items and has a function subscale (7 items) and bother subscale (7 items). For each domain, responses form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, where higher scores correspond to better quality of life. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Change was calculated as follow-up score - baseline score so a negative change score indicates a decline in function. Baseline and week 5 of RT
Secondary Percentage of Patients With Acute Grade 2+ GI Toxicity at 5 Weeks From the Start of Treatment Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE. The Common Terminology Criteria for Adverse Events (CTCAE) v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Baseline to Week 5 of RT
Secondary Urinary Toxicity, as Measured by Change in EPIC Urinary Domain The primary endpoint is change in acute GI toxicity, as measured by the EPIC urinary domain, from baseline to 5 weeks after the first fraction of radiation is delivered. The EPIC has four domains (bowel, urinary, sexual, and hormonal) that have been validated separately, which allows use of only the domains of interest. The EPIC urinary domain consists of 12 items and has a function subscale (5 items) and bother subscale (7 items). For each domain, responses form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, where higher scores correspond to better quality of life. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Change was calculated as follow-up score - baseline score so a negative change score indicates a decline in function. Baseline, week 3 and 5 of RT, and 4-6 weeks after RT
Secondary Quality of Life, as Measured by Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) and FACT-Cx (Cervix) Subscale The FACT-G is a validated, 27-item measure where a higher score represents higher QOL. In addition to a total QOL score, subscale scores for physical, functional, social and emotional well-being are produced. There are 5 responses options, with 0=Not a lot and 4=Very much. All items in a subscale are added together to obtain subscale totals. Scores range from 0-108 for the FACT-G total score, 0-28 for physical, social, functional, and 0-24 for emotional subscale. Certain items must be reversed before it is added by subtracting the response from 4. Subscale totals are summed to form the FACT-G total score. The FACT-Cx is 5-items, with score ranging 0-60, but is not included in total FACT-G. Each subscale requires >= 50% of items completed and overall response rate must be greater than 80%. If items are missing, the subscale scores can be prorated. Change calculated as follow-up score - baseline score so that a negative change score indicates a decline in function. Before study start, Week 5 of RT, 4-6 Weeks after RT, 1 year from start of RT and 3 years from start of RT
Secondary Health Utilities, as Measured by Change From Baseline in EQ-5D The EQ-5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). Health states are defined by the combination of the leveled responses to the 5 dimensions, generating 243 health states to which unconsciousness and death are added. The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Both the 5-item index score and the VAS score are transformed into a utility score between 0 (worst health state) and 1 (best health state). Change from baseline is calculated as score at the timepoint of interested - baseline score. Baseline, week 5 of RT, 4-6 weeks after RT
Secondary Local-regional Recurrence Local recurrence is defined as a disease in the radiation treatment field. This can include a local vaginal recurrence or nodal disease within the field. Para-aortic recurrence is defined as new lymphadenopathy in the para-aortic distribution. Local-regional control time is defined as time from randomization to the date of local recurrence, last known follow-up (censored), or death (competing risk). Local-regional recurrence rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year rates are provided. Analysis occurred after all patients had been on study for at least 3 years. From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months.
Secondary Disease-free Survival Disease (progression) is defined as local recurrence, para-aortic recurrence, or distant metastasis. Local recurrence is defined as a disease in the radiation treatment field. Para-aortic recurrence is defined as new lymphadenopathy in the para-aortic distribution. Distant metastasis is defined as involvement of another organ or peritoneal disease. Disease-free survival time is defined as time from randomization to the date of progression, death, or last known follow-up (censored). Disease-free survival rates are estimated using the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year rates are provided. Analysis occurred after all patients had been on study for at least 3 years. From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months.
Secondary Overall Survival Overall survival time is defined as time from registration/randomization to the date of death from any cause or last known follow-up (censored). Survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year rates are provided. Analysis occurred after all patients had been on study for at least 3 years. From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months.
Secondary Identification of Molecular Predictors of Radiation Toxicity and Novel Circulating Cancer Biomarkers Outcome measure will not be analyzed
Secondary Standardized Cronbach's Alpha for EPIC Bowel and Urinary Domains (Validation - Internal Consistency Reliability) The EPIC bowel domain consists of 14 items and has a function subscale (7 items) and bother subscale (7 items). The EPIC urinary domain consists of 12 total items and 4 subscales, functional (5 items), bother (7), incontinence (4) and irritative/obstructive (7). For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life. A domain score is the average of the transformed item scores. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Cronbach's alpha is an internal consistency estimate of reliability of psychometric test scores and is a function of the number of items in a test, the average covariance between item-pairs, and the variance of the total score. An alpha of 0.60-0.79 was to be considered acceptable reliability; higher than 0.8 was to be considered good reliability. Baseline and week 5 of RT
Secondary Spearman's Correlation Coefficient for EPIC Bowel Domain vs. Urinary Domains (Validation - Conceptual Independence) The EPIC bowel domain consists of 14 items and has a function subscale (7 items) and bother subscale (7 items). The EPIC urinary domain consists of 12 total items and 4 subscales, functional (5 items), bother (7), incontinence (4) and irritative/obstructive (7). For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life. A domain score is the average of the transformed item scores. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Spearman's rank correlation coefficient is a nonparametric measure of rank correlation between two variables with a value between +1 and -1, where 1 is total positive rank correlation, 0 is no rank correlation, and -1 is total negative rank correlation. Baseline and week 5 of RT
Secondary Pearson Correlation Coefficient for EPIC Bowel and Urinary Domains vs. FACT-G Total Score (Validation - Criterion Validity) The EPIC bowel domain and urinary domains consist of 14 and 12 items, respectively. For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life (QOL). A domain score is the average of the transformed item scores. At least 80% of the items in a domain must be completed in order to compute the score. The FACT-G is 27-item measure. Higher scores represent higher QOL. Each item has 5 responses options, 0=Not a lot and 4=Very much. Items are added together for the total score, ranging from 0-108. Certain items must be reversed before adding by subtracting the response from 4. The Pearson correlation coefficient is a measure of the linear correlation between two variables with a value between +1 and -1, where 1 is total positive linear correlation, 0 is no linear correlation, and -1 is total negative linear correlation. Baseline and week 5 of RT
Secondary Mean Change From Baseline in EPIC Bowel and Urinary Domain (Validation - Sensitivity to Treatment) The EPIC bowel domain and urinary domains consist of 14 and 12 items, respectively. For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life (QOL). A domain score is the average of the transformed item scores. At least 80% of the items in a domain must be completed in order to compute the score. Difference is calculated as baseline - week 5.
A positive change score represents a decline in function.
Baseline and week 5 of RT
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