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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM 1 daily boost | Active Comparator | Radiation Therapy |
|
| ARM 2 weekly boost | Active Comparator | Radiation Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daily Radiation Therapy | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carmen Perez, MD | NYU School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bellevue Hospital Center | New York | New York | 10016 | United States | ||
| NYU Clinical Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27131077 | Result | 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 Daily Versus Weekly Boost to the Tumor Bed. Int J Radiat Oncol Biol Phys. 2016 Jun 1;95(2):571-8. doi: 10.1016/j.ijrobp.2015.12.373. Epub 2015 Dec 29. | |
| 24161428 |
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| ID | Title | Description |
|---|---|---|
| FG000 | ARM 1 Daily Boost | 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. |
| FG001 | ARM 2 Weekly Boost | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ARM 1 Daily Boost | Radiation Therapy Radiation Therapy: Arm 1= 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. Arm 2= 15 daily 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Patients receiving either daily or weekly boost to radiation therapy | Posted | Number | participants | Day 60 |
|
Day 1 of radiation therapy to Day 60
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ARM 1 Daily Boost | Radiation Therapy Radiation Therapy: Arm 1= 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. Arm 2= 15 daily 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Edema (Grade 1) | Respiratory, thoracic and mediastinal disorders | RTOG/EORTC | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Silvia Formenti, Chairman, Department of Radiation Oncology | NYU Langone Medical Center | (212) 731-5039 | silvia.formenti@nyumc.org |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| Weekly Radiation Therapy | Radiation | 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. |
|
| Baseline |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| New York |
| New York |
| 10016 |
| United States |
| Tisch Hospital | New York | New York | 10016 | United States |
| Result |
| 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 high-dose-rate interstitial brachytherapy for early-stage breast cancer. Int J Radiat Oncol Biol Phys. 2013 Dec 1;87(5):1043-50. doi: 10.1016/j.ijrobp.2013.09.009. Epub 2013 Oct 22. |
| 27045811 | Derived | Finkel MA, Cooper BT, Li X, Fenton-Kerimian M, Goldberg JD, Formenti SC. Quality of Life in Women Undergoing Breast Irradiation in a Randomized, Controlled Clinical Trial Evaluating Different Tumor Bed Boost Fractionations. Int J Radiat Oncol Biol Phys. 2016 Jun 1;95(2):579-89. doi: 10.1016/j.ijrobp.2016.02.004. Epub 2016 Feb 6. |
| BG001 | ARM 2 Weekly Boost | Radiation Therapy Radiation Therapy: Arm 1= 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. Arm 2= 15 daily 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | ARM 2 Weekly Boost | Radiation Therapy Radiation Therapy: Arm 1= 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. Arm 2= 15 daily 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. |
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 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". | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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". | Posted | Mean | Standard Deviation | score on a scale | 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". | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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" | Posted | Mean | Standard Deviation | score on a scale | 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." | Posted | Mean | Standard Deviation | score on a scale | 45-60 days after treatment |
|
|
|
| 0 |
| 202 |
| 89 |
| 202 |
| EG001 | ARM 2 Weekly Boost | Radiation Therapy Radiation Therapy: Arm 1= 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. Arm 2= 15 daily 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. | 0 | 198 | 72 | 198 |
| Fibrosis (Grade 1) | Reproductive system and breast disorders | RTOG/EORTC | Systematic Assessment |
|
| Pain (Grade 1) | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Pigmentation Change (Grade 1) | Skin and subcutaneous tissue disorders | RTOG/EORTC | Non-systematic Assessment |
|
| Retraction/Atrophy (Grade 1) | Skin and subcutaneous tissue disorders | RTOG/EORTC | Non-systematic Assessment |
|
| Telangiectasia (Grade 1) | Skin and subcutaneous tissue disorders | RTOG/EORTC | Non-systematic Assessment |
|
| Lymphedema (Grade 1) | Blood and lymphatic system disorders | RTOG/EORTC | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| Breast Specific Pain |
|
| Convenience of Care |
|
| Breast Specific Pain |
|
| Breast Specific Pain |
|