Study Comparing Whole Breast Radiotherapy With a Daily Versus a Weekly Tumor

Breast Cancer Clinical Trial

Official title:

Phase III Study Comparing Whole Breast Radiotherapy With a Daily Tumor Red Boost

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01000662
• Other study ID #: 09-0030
• Status: Completed
• Phase: Phase 3
• Start date: March 2009
• Est. completion date: June 14, 2017

Study information

• Verified date: July 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

All patients (with Stages 0-II breast cancer) will receive an accelerated three week regimen of prone whole breast radiotherapy. The study intends to test the hypothesis that a weekly boost to the tumor bed, delivered on Friday, before the weekend break, is as well tolerated as the daily boost during accelerated prone radiotherapy.

Description:

Arm 1 is a concomitant boost protocol over three weeks which has previously been evaluated in over 500 patients (NYU 03-30 and NYU 05-181) and has shown excellent tolerance, and results. Arm 2 evaluates a Weekend Boost Dose (WBD) regimen which may have a radiobiological advantage by counteracting tumor repopulation which can occur over the weekend break. At the time of registration in the study, patients will be randomized to either treatment arm and stratified according to pre or post-menopausal status and on previous chemotherapy received or not.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 412
• Est. completion date: June 14, 2017
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pre or post-menopausal women with stage 0,I, and II breast cancer

• Biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm

• Status post segmental mastectomy, after sentinel node biopsy and/or axillary node dissection (DCIS and Tumors <5mm do not require nodal assessment)

• At least 2 weeks from last chemotherapy

• Patient needs to be able to understand and demonstrate willingness to sign a written informed consent document

Exclusion Criteria:

• Previous radiation therapy to the ipsilateral breast

• More than 3 involved nodes identified at axillary staging, requiring adjuvant axillary radiation

• Active connective tissue disorders, such as lupus or scleroderma

• Prior or concurrent malignancy other than basal or squamous cell skin cancer or carcinoma in-situ of the cervix, unless disease-free >3 years

• Pregnant or lactating women

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Radiation:
• Daily Radiation Therapy
15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.
• Weekly Radiation Therapy
15 weekly radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.

Locations

Country	Name	City	State
United States	Bellevue Hospital Center	New York	New York
United States	NYU Clinical Cancer Center	New York	New York
United States	Tisch Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

References & Publications (2)

Cooper BT, Formenti-Ujlaki GF, Li X, Shin SM, Fenton-Kerimian M, Guth A, Roses DF, Hitchen CJ, Rosenstein BS, Dewyngaert JK, Goldberg JD, Formenti SC. Prospective Randomized Trial of Prone Accelerated Intensity Modulated Breast Radiation Therapy With a Da — View Citation

Garsa AA, Ferraro DJ, DeWees TA, Deshields TL, Margenthaler JA, Cyr AE, Naughton M, Aft R, Gillanders WE, Eberlein T, Matesa MA, Ochoa LL, Zoberi I. A prospective longitudinal clinical trial evaluating quality of life after breast-conserving surgery and h — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Acute Radiation Toxicities Recorded According to Radiation Therapy Oncology Group (RTOG)	Number of patients with a grade 2 or greater toxicity after 3 weeks of whole breast IMRT with a once/week boost compared to those patients treated with a daily boost: 0 - no symptoms, 5 - death directly related to radiation effects	Day 60
Secondary	Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at Baseline	BCTOS is a validated questionnaire designed to measure breast esthetic and function after breast-conservations treatment. Patients rate the difference between their untreated and treated breast in 3 categories.; There are 4 score levels: 1 = "No difference"; 2 = "Slight"; 3 = "Moderate"; 4 = "Large difference". The total range is 3-12; the lower the score the lower the difference between the untreated and treated breast.	Baseline
Secondary	Score on "SF-36 v2 Vitality" Scale	SF-36 is an extensively used questionnaire designed to compare health status across various populations and is commonly used in cancer trials Our survey includes the portion of the SF-36 focused on the assessment of patient fatigue, or "vitality," at various stages of treatment Example question: How much of the time during the past 4 weeks did you feel full of life? (Answer on scale 1 to 5). 1 = "All of the time"; 2 = "Most of the time"; 3 = "Some of the time"; 4 = "A little of the time"; 5 = "None of the time".	Baseline
Secondary	Average Score on Brief Pain Inventory (BPI) Scale	The BPI is a self-administered assessment tool used in pain management.; The BPI scale defines pain as follows: 1-4 = Mild Pain 5-6 = Moderate Pain 7-10 = Severe Pain; The total range is 1-10; the higher the score, the higher the pain level.	Baseline
Secondary	Average Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale	4 levels: 1 = "Excellent"; 2 = "Good"; 3 = "Fair"; 4 = "Poor." The total range is 1-4; the higher the score, the lower the breast quality.	Baseline
Secondary	Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at the End of Treatment	BCTOS is a validated questionnaire designed to measure breast esthetic and function after breast-conservations treatment. Patients rate the difference between their untreated and treated breast in 3 categories.; There are 4 score levels: 1 = "No difference"; 2 = "Slight"; 3 = "Moderate"; 4 = "Large difference". The total range is 3-12; the lower the score the lower the difference between the untreated and treated breast.	At the end of Treatment, an average of 3 weeks
Secondary	Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS)	BCTOS is a validated questionnaire designed to measure breast esthetic and function after breast-conservations treatment. Patients rate the difference between their untreated and treated breast in 3 categories.; There are 4 score levels: 1 = "No difference"; 2 = "Slight"; 3 = "Moderate"; 4 = "Large difference". The total range is 3-12; the lower the score the lower the difference between the untreated and treated breast.	45-60 days after treatment
Secondary	Score on "SF-36 v2 Vitality" Scale	SF-36 is an extensively used questionnaire designed to compare health status across various populations and is commonly used in cancer trials Our survey includes the portion of the SF-36 focused on the assessment of patient fatigue, or "vitality," at various stages of treatment Example question: How much of the time during the past 4 weeks did you feel full of life? (Answer on scale 1 to 5). 1 = "All of the time"; 2 = "Most of the time"; 3 = "Some of the time"; 4 = "A little of the time"; 5 = "None of the time".	End of Treatment
Secondary	Score on "SF-36 v2 Vitality" Scale 45-60 Days After Treatment	SF-36 is an extensively used questionnaire designed to compare health status across various populations and is commonly used in cancer trials Our survey includes the portion of the SF-36 focused on the assessment of patient fatigue, or "vitality," at various stages of treatment Example question: How much of the time during the past 4 weeks did you feel full of life? (Answer on scale 1 to 5). 1 = "All of the time"; 2 = "Most of the time"; 3 = "Some of the time"; 4 = "A little of the time"; 5 = "None of the time".	45-60 days after treatment
Secondary	Average Score on Brief Pain Inventory (BPI)	The BPI is a self-administered assessment tool used in pain management.; The BPI scale defines pain as follows: 1-4 = Mild Pain 5-6 = Moderate Pain 7-10 = Severe Pain; The total range is 1-10; the higher the score, the higher the pain level.	At the end of Treatment, an average of 3 weeks
Secondary	Average Score on Brief Pain Inventory (BPI)	The BPI is a self-administered assessment tool used in pain management.; The BPI scale defines pain as follows: 1-4 = Mild Pain 5-6 = Moderate Pain 7-10 = Severe Pain; The total range is 1-10; the higher the score, the higher the pain level.	45-60 days after treatment
Secondary	Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, at End of Treatment	4 levels: 1 = "Excellent"; 2 = "Good"; 3 = "Fair"; 4 = "Poor"	End of Treatment
Secondary	Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, 45-60 Days After Treatment	4 levels: 1 = "Excellent"; 2 = "Good"; 3 = "Fair"; 4 = "Poor."	45-60 days after treatment