Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Phase III, Randomized, Study of Sulfasalazine Versus Placebo in the Prevention of Acute Diarrhea in Patients Receiving Pelvic Radiation Therapy
Verified date | April 2020 |
Source | Alliance for Clinical Trials in Oncology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Sulfasalazine may relieve diarrhea in patients with cancer who are undergoing
pelvic radiation therapy.
PURPOSE: This randomized phase III trial is studying sulfasalazine to see how well it works
in preventing acute diarrhea in patients with cancer who are undergoing pelvic radiation
therapy.
Status | Completed |
Enrollment | 87 |
Est. completion date | July 15, 2017 |
Est. primary completion date | July 22, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Diagnosis of cancer that supports the use of radiotherapy to the pelvis - No current or prior metastases beyond pelvic regional lymph nodes - Planning to receive a course of continuous definitive or adjuvant external-beam radiotherapy to a minimum dose of 4500 cGy with or without fluorouracil, capecitabine, or oxaliplatin - Planned course of pelvic radiotherapy must fall within the following parameters: - Pelvis must be encompassed by the planned radiotherapy fields - Superior border may not lie superior to the L4-5 interspace and may not be inferior to the most inferior aspect of the sacroiliac joints - Portions of the rectum may have special blocking, depending upon disease site - Total planned dose to the central axis midplane (for AP-PA parallel opposed fields) or isocenter (for 3- or 4-field techniques) for the pelvic field must lie between 4500-5300 cGy (inclusive)* - Subsequent to completion of treatment to the pelvic field, a boost to primary tumor or tumor bed may be planned - Planned treatment is to be given 4-5 times per week on a one-treatment-per-day basis - Daily dose (specified at central axis midplane or at isocenter for multi-field techniques) must lie between 170-210 cGy (inclusive) per day* - NOTE: *For institutions that do not use midplane or isocenter as the point for specification of dose, it will be necessary to determine the dose according to the methods specified above in order to determine patient eligibility. - No perineal irradiation planned (e.g., anal cancer patients, patients who have had an abdominal-perineal resection) - No brachytherapy planned before the completion of all external-beam radiotherapy - No planned split-course radiotherapy PATIENT CHARACTERISTICS: - ECOG performance status 0-2 - Life expectancy = 6 months - Hemoglobin = 10.0 g/dL - Leukocytes = 3,500/mm^3 - ANC = 1,500/mm^3 - Platelet count = 100,000/mm^3 - Creatinine = 1.5 times upper limit of normal (ULN) - AST = 1.5 times ULN - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Willing to provide blood specimens as required by the study (Mayo Clinic Rochester patients only) - Able to complete questionnaires alone or with assistance - No history of inflammatory bowel disease - No history of gastrointestinal or genitourinary obstruction or porphyria - No history of G6PD deficiency - No history of irritable bowel syndrome - No history of blood dyscrasia - No history of severe allergies or asthma - No history of hepatic or renal disease - No diarrhea = grade 3, rectal bleeding, abdominal cramping, or incontinence of stool within the past week - No medical condition that may interfere with the ability to receive study treatment - No known allergy to sulfasalazine, sulfa medications, salicylates, or any known component of drug formulation PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No prior pelvic radiotherapy - No prior abdominal-perineal resection, Hartmann procedure, or other surgical procedure leaving the patient without a functioning rectum - No planned use of leucovorin or cytotoxic chemotherapeutic agents concurrent with radiotherapy (except for fluorouracil, capecitabine, or oxaliplatin) - No other concurrent sulfasalazine - No concurrent digoxin |
Country | Name | City | State |
---|---|---|---|
United States | Kapiolani Medical Center at Pali Momi | 'Aiea | Hawaii |
United States | Hickman Cancer Center at Bixby Medical Center | Adrian | Michigan |
United States | University of New Mexico Cancer Center | Albuquerque | New Mexico |
United States | AnMed Cancer Center | Anderson | South Carolina |
United States | CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan |
United States | Saint Joseph Mercy Cancer Center | Ann Arbor | Michigan |
United States | Randolph Hospital | Asheboro | North Carolina |
United States | MBCCOP - Medical College of Georgia Cancer Center | Augusta | Georgia |
United States | Aurora Presbyterian Hospital | Aurora | Colorado |
United States | Rush-Copley Cancer Care Center | Aurora | Illinois |
United States | MeritCare Bemidji | Bemidji | Minnesota |
United States | Billings Clinic - Downtown | Billings | Montana |
United States | CCOP - Montana Cancer Consortium | Billings | Montana |
United States | Hematology-Oncology Centers of the Northern Rockies - Billings | Billings | Montana |
United States | St. Vincent Healthcare Cancer Care Services | Billings | Montana |
United States | Medcenter One Hospital Cancer Care Center | Bismarck | North Dakota |
United States | Mid Dakota Clinic, PC | Bismarck | North Dakota |
United States | St. Alexius Medical Center Cancer Center | Bismarck | North Dakota |
United States | Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Boise | Idaho |
United States | Central Care Cancer Center at Carrie J. Babb Cancer Center | Bolivar | Missouri |
United States | Boston University Cancer Research Center | Boston | Massachusetts |
United States | Boulder Community Hospital | Boulder | Colorado |
United States | Wood County Oncology Center | Bowling Green | Ohio |
United States | Bozeman Deaconess Cancer Center | Bozeman | Montana |
United States | St. Joseph's Medical Center | Brainerd | Minnesota |
United States | Fairview Ridges Hospital | Burnsville | Minnesota |
United States | St. James Healthcare Cancer Care | Butte | Montana |
United States | Southeast Cancer Center | Cape Girardeau | Missouri |
United States | Cedar Rapids Oncology Associates | Cedar Rapids | Iowa |
United States | Mercy Regional Cancer Center at Mercy Medical Center | Cedar Rapids | Iowa |
United States | Cancer Center of Kansas, PA - Chanute | Chanute | Kansas |
United States | Louis A. Weiss Memorial Hospital | Chicago | Illinois |
United States | Adena Regional Medical Center | Chillicothe | Ohio |
United States | Medical Oncology and Hematology Associates - West Des Moines | Clive | Iowa |
United States | Mercy Cancer Center - West Lakes | Clive | Iowa |
United States | Penrose Cancer Center at Penrose Hospital | Colorado Springs | Colorado |
United States | Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus | Ohio |
United States | CCOP - Columbus | Columbus | Ohio |
United States | Doctors Hospital at Ohio Health | Columbus | Ohio |
United States | Grant Medical Center Cancer Care | Columbus | Ohio |
United States | Mount Carmel Health - West Hospital | Columbus | Ohio |
United States | Riverside Methodist Hospital Cancer Care | Columbus | Ohio |
United States | New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care | Concord | New Hampshire |
United States | Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids | Minnesota |
United States | CCOP - Dayton | Dayton | Ohio |
United States | David L. Rike Cancer Center at Miami Valley Hospital | Dayton | Ohio |
United States | Good Samaritan Hospital | Dayton | Ohio |
United States | Grandview Hospital | Dayton | Ohio |
United States | Samaritan North Cancer Care Center | Dayton | Ohio |
United States | Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn | Michigan |
United States | Grady Memorial Hospital | Delaware | Ohio |
United States | Porter Adventist Hospital | Denver | Colorado |
United States | Presbyterian - St. Luke's Medical Center | Denver | Colorado |
United States | Rose Medical Center | Denver | Colorado |
United States | St. Anthony Central Hospital | Denver | Colorado |
United States | St. Joseph Hospital | Denver | Colorado |
United States | CCOP - Iowa Oncology Research Association | Des Moines | Iowa |
United States | John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines | Iowa |
United States | John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines | Iowa |
United States | Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines | Iowa |
United States | Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines | Iowa |
United States | Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines | Iowa |
United States | Cancer Center of Kansas, PA - Dodge City | Dodge City | Kansas |
United States | CCOP - Duluth | Duluth | Minnesota |
United States | Essentia Health - Duluth Clinic | Duluth | Minnesota |
United States | Miller - Dwan Medical Center | Duluth | Minnesota |
United States | Center for Cancer Treatment & Prevention at Sacred Heart Hospital | Eau Claire | Wisconsin |
United States | Marshfield Clinic Cancer Care at Regional Cancer Center | Eau Claire | Wisconsin |
United States | Fairview Southdale Hospital | Edina | Minnesota |
United States | Cancer Center of Kansas, PA - El Dorado | El Dorado | Kansas |
United States | Elkhart Clinic, LLC | Elkhart | Indiana |
United States | Elkhart General Hospital | Elkhart | Indiana |
United States | Michiana Hematology-Oncology, PC - Elkhart | Elkhart | Indiana |
United States | Union Hospital of Cecil County | Elkton | Maryland |
United States | Community Cancer Center | Elyria | Ohio |
United States | Hematology Oncology Center | Elyria | Ohio |
United States | Swedish Medical Center | Englewood | Colorado |
United States | MeritCare Broadway | Fargo | North Dakota |
United States | Blanchard Valley Medical Associates | Findlay | Ohio |
United States | Genesys Hurley Cancer Institute | Flint | Michigan |
United States | Hurley Medical Center | Flint | Michigan |
United States | Central Wisconsin Cancer Program at Agnesian HealthCare | Fond Du Lac | Wisconsin |
United States | Cancer Center of Kansas - Fort Scott | Fort Scott | Kansas |
United States | Middletown Regional Hospital | Franklin | Ohio |
United States | Fredericksburg Oncology, Incorporated | Fredericksburg | Virginia |
United States | Mercy and Unity Cancer Center at Unity Hospital | Fridley | Minnesota |
United States | CaroMont Cancer Center at Gaston Memorial Hospital | Gastonia | North Carolina |
United States | Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina |
United States | Altru Cancer Center at Altru Hospital | Grand Forks | North Dakota |
United States | Benefis Sletten Cancer Institute | Great Falls | Montana |
United States | North Colorado Medical Center | Greeley | Colorado |
United States | Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay | Wisconsin |
United States | Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin |
United States | St. Mary's Hospital Medical Center - Green Bay | Green Bay | Wisconsin |
United States | St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin |
United States | Moses Cone Regional Cancer Center at Wesley Long Community Hospital | Greensboro | North Carolina |
United States | Bon Secours St. Francis Health System | Greenville | South Carolina |
United States | Cancer Centers of the Carolinas - Faris Road | Greenville | South Carolina |
United States | CCOP - Greenville | Greenville | South Carolina |
United States | Greenville Hospital Cancer Center | Greenville | South Carolina |
United States | Wayne Hospital | Greenville | Ohio |
United States | Legacy Mount Hood Medical Center | Gresham | Oregon |
United States | Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan |
United States | Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford | Connecticut |
United States | Ingalls Cancer Care Center at Ingalls Memorial Hospital | Harvey | Illinois |
United States | St. Peter's Hospital | Helena | Montana |
United States | Park Ridge Hospital | Hendersonville | North Carolina |
United States | High Point Regional Hospital | High Point | North Carolina |
United States | Cancer Research Center of Hawaii | Honolulu | Hawaii |
United States | Hawaii Medical Center - East | Honolulu | Hawaii |
United States | Kapiolani Medical Center for Women and Children | Honolulu | Hawaii |
United States | OnCare Hawaii, Incorporated - Kuakini | Honolulu | Hawaii |
United States | OnCare Hawaii, Incorporated - Lusitana | Honolulu | Hawaii |
United States | Queen's Cancer Institute at Queen's Medical Center | Honolulu | Hawaii |
United States | Straub Clinic and Hospital, Incorporated | Honolulu | Hawaii |
United States | Tripler Army Medical Center | Honolulu | Hawaii |
United States | New Hampshire Oncology - Hematology, PA - Hooksett | Hooksett | New Hampshire |
United States | Edwards Comprehensive Cancer Center at Cabell Huntington Hospital | Huntington | West Virginia |
United States | Hutchinson Area Health Care | Hutchinson | Minnesota |
United States | Cancer Center of Kansas-Independence | Independence | Kansas |
United States | St. Francis Hospital Cancer Care Services | Indianapolis | Indiana |
United States | Foote Memorial Hospital | Jackson | Michigan |
United States | Goldschmidt Cancer Center | Jefferson City | Missouri |
United States | Kalispell Regional Medical Center | Kalispell | Montana |
United States | Charles F. Kettering Memorial Hospital | Kettering | Ohio |
United States | Cancer Center of Kansas, PA - Kingman | Kingman | Kansas |
United States | Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center | Kingsport | Tennessee |
United States | Howard Community Hospital | Kokomo | Indiana |
United States | Gundersen Lutheran Center for Cancer and Blood | La Crosse | Wisconsin |
United States | Lakes Region General Hospital | Laconia | New Hampshire |
United States | Fairfield Medical Center | Lancaster | Ohio |
United States | Sparrow Regional Cancer Center | Lansing | Michigan |
United States | University of New Mexico Cancer Center - South | Las Cruces | New Mexico |
United States | Lawrence Memorial Hospital | Lawrence | Kansas |
United States | Tunnell Cancer Center at Beebe Medical Center | Lewes | Delaware |
United States | Cancer Center of Kansas, PA - Liberal | Liberal | Kansas |
United States | Lima Memorial Hospital | Lima | Ohio |
United States | Cancer Resource Center - Lincoln | Lincoln | Nebraska |
United States | St. Mary Mercy Hospital | Livonia | Michigan |
United States | Sky Ridge Medical Center | Lone Tree | Colorado |
United States | Hope Cancer Care Center at Longmont United Hospital | Longmont | Colorado |
United States | McKee Medical Center | Loveland | Colorado |
United States | Holy Family Memorial Medical Center Cancer Care Center | Manitowoc | Wisconsin |
United States | Immanuel St. Joseph's | Mankato | Minnesota |
United States | HealthEast Cancer Care at St. John's Hospital | Maplewood | Minnesota |
United States | Minnesota Oncology - Maplewood | Maplewood | Minnesota |
United States | Strecker Cancer Center at Marietta Memorial Hospital | Marietta | Ohio |
United States | Bay Area Cancer Care Center at Bay Area Medical Center | Marinette | Wisconsin |
United States | Marshfield Clinic - Marshfield Center | Marshfield | Wisconsin |
United States | Saint Joseph's Hospital | Marshfield | Wisconsin |
United States | Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County | Martinsville | Virginia |
United States | Northwest Ohio Oncology Center | Maumee | Ohio |
United States | Hennepin County Medical Center - Minneapolis | Minneapolis | Minnesota |
United States | Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis | Minnesota |
United States | Marshfield Clinic - Lakeland Center | Minocqua | Wisconsin |
United States | Michiana Hematology-Oncology, PC - South Bend | Mishawaka | Indiana |
United States | Saint Joseph Regional Medical Center | Mishawaka | Indiana |
United States | Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula | Montana |
United States | Montana Cancer Specialists at Montana Cancer Center | Missoula | Montana |
United States | Trinity Cancer Center at Trinity Medical Center - 7th Street Campus | Moline | Illinois |
United States | Community Cancer Center of Monroe | Monroe | Michigan |
United States | Mercy Memorial Hospital - Monroe | Monroe | Michigan |
United States | Mount Kisco Medical Group, PC | Mount Kisco | New York |
United States | Knox Community Hospital | Mount Vernon | Ohio |
United States | Ochsner Cancer Institute at Ochsner Clinic Foundation | New Orleans | Louisiana |
United States | CCOP - Christiana Care Health Services | Newark | Delaware |
United States | Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark | Ohio |
United States | Cancer Center of Kansas, PA - Newton | Newton | Kansas |
United States | Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha | Nebraska |
United States | CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska |
United States | Creighton University Medical Center | Omaha | Nebraska |
United States | Immanuel Medical Center | Omaha | Nebraska |
United States | Lakeside Hospital | Omaha | Nebraska |
United States | St. Charles Mercy Hospital | Oregon | Ohio |
United States | Toledo Clinic - Oregon | Oregon | Ohio |
United States | Cancer Center of Kansas, PA - Parsons | Parsons | Kansas |
United States | Mayo Clinic Hospital | Phoenix | Arizona |
United States | Michiana Hematology Oncology PC - Plymouth | Plymouth | Indiana |
United States | St. Joseph Mercy Oakland | Pontiac | Michigan |
United States | Mercy Regional Cancer Center at Mercy Hospital | Port Huron | Michigan |
United States | Legacy Good Samaritan Hospital & Comprehensive Cancer Center | Portland | Oregon |
United States | Cancer Center of Kansas, PA - Pratt | Pratt | Kansas |
United States | St. Mary - Corwin Regional Medical Center | Pueblo | Colorado |
United States | Rapid City Regional Hospital | Rapid City | South Dakota |
United States | Annie Penn Cancer Center | Reidsville | North Carolina |
United States | Ministry Medical Group at Saint Mary's Hospital | Rhinelander | Wisconsin |
United States | Marshfield Clinic - Indianhead Center | Rice Lake | Wisconsin |
United States | Reid Hospital & Health Care Services | Richmond | Indiana |
United States | Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale | Minnesota |
United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
United States | Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw | Michigan |
United States | Lakeland Regional Cancer Care Center - St. Joseph | Saint Joseph | Michigan |
United States | Lakeside Cancer Specialists, PLLC | Saint Joseph | Michigan |
United States | Missouri Baptist Cancer Center | Saint Louis | Missouri |
United States | CCOP - Metro-Minnesota | Saint Louis Park | Minnesota |
United States | Park Nicollet Cancer Center | Saint Louis Park | Minnesota |
United States | Regions Hospital Cancer Care Center | Saint Paul | Minnesota |
United States | United Hospital | Saint Paul | Minnesota |
United States | Cancer Center of Kansas, PA - Salina | Salina | Kansas |
United States | Mayo Clinic Scottsdale | Scottsdale | Arizona |
United States | Cancer Centers of the Carolinas - Seneca | Seneca | South Carolina |
United States | St. Francis Cancer Center at St. Francis Medical Center | Shakopee | Minnesota |
United States | St. Nicholas Hospital | Sheboygan | Wisconsin |
United States | Mercy Medical Center - Sioux City | Sioux City | Iowa |
United States | Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa |
United States | St. Luke's Regional Medical Center | Sioux City | Iowa |
United States | Avera Cancer Institute | Sioux Falls | South Dakota |
United States | Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls | South Dakota |
United States | CCOP - Northern Indiana CR Consortium | South Bend | Indiana |
United States | Memorial Hospital of South Bend | South Bend | Indiana |
United States | Cancer Centers of the Carolinas - Spartanburg | Spartanburg | South Carolina |
United States | CCOP - Upstate Carolina | Spartanburg | South Carolina |
United States | Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg | South Carolina |
United States | CCOP - Cancer Research for the Ozarks | Springfield | Missouri |
United States | Community Hospital of Springfield and Clark County | Springfield | Ohio |
United States | Hulston Cancer Center at Cox Medical Center South | Springfield | Missouri |
United States | Iredell Memorial Hospital | Statesville | North Carolina |
United States | Marshfield Clinic at Saint Michael's Hospital | Stevens Point | Wisconsin |
United States | Saint Michael's Hospital Cancer Center | Stevens Point | Wisconsin |
United States | Lakeview Hospital | Stillwater | Minnesota |
United States | Door County Cancer Center at Door County Memorial Hospital | Sturgeon Bay | Wisconsin |
United States | Flower Hospital Cancer Center | Sylvania | Ohio |
United States | North Suburban Medical Center | Thornton | Colorado |
United States | Mercy Hospital of Tiffin | Tiffin | Ohio |
United States | Medical University of Ohio Cancer Center | Toledo | Ohio |
United States | St. Anne Mercy Hospital | Toledo | Ohio |
United States | St. Vincent Mercy Medical Center | Toledo | Ohio |
United States | Toledo Clinic, Incorporated - Main Clinic | Toledo | Ohio |
United States | Toledo Hospital | Toledo | Ohio |
United States | UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio |
United States | Legacy Meridian Park Hospital | Tualatin | Oregon |
United States | Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa | Oklahoma |
United States | CCOP - Carle Cancer Center | Urbana | Illinois |
United States | Legacy Salmon Creek Medical Center | Vancouver | Washington |
United States | Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees | New Jersey |
United States | Ridgeview Medical Center | Waconia | Minnesota |
United States | St. John Macomb Hospital | Warren | Michigan |
United States | Fulton County Health Center | Wauseon | Ohio |
United States | Cancer Center of Kansas, PA - Wellington | Wellington | Kansas |
United States | Methodist West Hospital | West Des Moines | Iowa |
United States | Mount Carmel St. Ann's Cancer Center | Westerville | Ohio |
United States | Marshfield Clinic - Weston Center | Weston | Wisconsin |
United States | Ministry Saint Clare's Hospital | Weston | Wisconsin |
United States | Michiana Hematology Oncology PC - La Porte | Westville | Indiana |
United States | Exempla Lutheran Medical Center | Wheat Ridge | Colorado |
United States | Associates in Womens Health, PA - North Review | Wichita | Kansas |
United States | Cancer Center of Kansas, PA - Medical Arts Tower | Wichita | Kansas |
United States | Cancer Center of Kansas, PA - Wichita | Wichita | Kansas |
United States | CCOP - Wichita | Wichita | Kansas |
United States | Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita | Kansas |
United States | Willmar Cancer Center at Rice Memorial Hospital | Willmar | Minnesota |
United States | Cancer Center of Kansas, PA - Winfield | Winfield | Kansas |
United States | Minnesota Oncology - Woodbury | Woodbury | Minnesota |
United States | Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio |
United States | Genesis - Good Samaritan Hospital | Zanesville | Ohio |
Lead Sponsor | Collaborator |
---|---|
Alliance for Clinical Trials in Oncology | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After Radiotherapy (RT) | The primary endpoint for this study is the maximal severity of diarrhea toxicity. Severity of diarrhea was graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening as measured by the CTCAE version 4.0. Assessments were recorded during the course of RT and for 6 weeks following RT. The table below represents the worst graded diarrhea for each patient. A two-sided Wilcoxon rank-sum test will be used to test the equality of the distributions of maximum diarrhea severity grades between the two treatment arms. |
During radiation therapy and up to 6 weeks post radiation therapy | |
Secondary | Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT | The maximal severity of each of 5 different adverse even types (Tenesmus, Abdominal Pain, Constipation, Diarrhea, and Rectal Bleeding) were collected as a secondary endpoint. Severity of the events was graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening. Adverse events were assessed during the course of RT and for 6 weeks following RT. The table below represents the worst grade for each patient for each type. Two-sided chi-square tests will be used to compare each percentage variable between treatment arms for each event type. |
During radiation therapy and up to 6 weeks post radiation therapy | |
Secondary | Area Under the Curve That Combines the Individual Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After RT | For each patient, an Area Under the Curve (AUC) summary statistic will be calculated taking into account the individual severity of diarrhea toxicity over time. Severity of diarrhea was graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening. The curve was constructed using weekly assessments during and after RT. A separate analysis was done during the course of RT and every week for 6 weeks following RT. | During radiation therapy and up to 6 weeks post radiation therapy | |
Secondary | Average Graded Severity for Tenesmus, Abdominal Pain, Constipation, Diarrhea and Hemorrhage During and After RT as Graded by CTCAE v4.0 | Tenesmus, Abdominal pain, constipation, diarrhea and hemorrhaging were assessed during RT and up to 6 weeks after RT. Severity of these events were graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening. For each patient, an average score for each outcome variable during and after RT calculated as follows: The sum of all severity scores for that variable divided by the number of severity scores for that variable recorded for the patient during the course of RT and for 6 weeks following RT. | During radiation therapy and up to 6 weeks post radiation therapy | |
Secondary | Percentage of Patients in Each Arm That Experience Tenesmus, Abdominal Pain, Constipation, Diarrhea and Rectal Bleeding During and After RT | The number of patients that reported any grade 1 or higher adverse event was divided by the total number of patients evaluated. The analysis was done separately for each of the 5 outcomes and separately during RT and after RT. | During radiation therapy and up to 6 weeks post radiation therapy | |
Secondary | Percent of Patients in Each Arm That Recorded "Yes" to Each of Questions 2-10 on the Bowel Function Questionnaire | Questions that were used in this analysis: 2. Have you had a problem causing you to get up at night to have a bowel movement? 3. Have you had a problem causing you to lose control of your bowel movements? 4. Have you had a problem causing you to have a bowel movement within 30 minutes of a prior bowel movement? 5. Have you had to wear protective clothing or a pad in case you lost control of a bowel movement? 6. Have you had a problem causing you to be unable to tell the difference between stool and gas? 7. Have you had a problem causing you to have stools that are liquid? 1=yes 2=no q08 8. Have you found that once you feel the urge to have a bowel movement, you must do so within 15 minutes to avoid an accident? 9. Have you had cramping with a bowel movement? 10. Have you had blood in your bowel movement? |
Up to 6 weeks post radiation therapy | |
Secondary | Percentage of Patients in Each Arm That Require Any Type of Antidiarrheal Medications. | The number of patients reporting the use of anti-diarrheal medications divided by the number of patients evaluated for this endpoint. | Up to 24 months post radiotherapy | |
Secondary | Percentage of Patients in Each Arm That Experience Clinically Significant Deficits in Overall Quality of Life and Fatigue | For each arm, the percentage of patients experience clinically significant deficits in overall QOL and fatigue as indicated by a score of 5 or lower on the 0-10 scale. The analysis was done using the questionnaire that was completed during the first week of radiotherapy (RT) and 6 weeks after RT. | Up to 6 weeks post radiotherapy |
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