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During the past ten years the Breast Cancer Radiotherapy Research team at NYU has conducted a series of consecutive studies to optimize the safe delivery of accelerated radiotherapy to partial and whole breast in the prone position, as summarized in a recent review of this experience. The current protocol focuses on whole breast radiotherapy for women with stage 0-2 breast cancer treated by segmental mastectomy: it aims at further refining the role of prone IMRT versus a 3D-conformal radiotherapy technique in this common subset of patients.
This study is an open label randomized trial. Patients will be randomized within cohort defined by assigned treatment (3D CRT if IMRT not covered or IMRT) and within these primary strata by menopausal status (pre/post) and by chemotherapy prior to radiation (yes/no). The on-site treatment randomization assignments will done on site and treatment assignments will be provided to the Research Nurse after she has confirmed eligibility. Patients will be randomized within the primary strata based on presumed insurance coverage on consent to the study to allow simulation to proceed. Should the coverage change, then the patient will be re-randomized in the correct stratum and the initial randomization number will be retired with a notation that the initial stratification was revised and patient re-randomized.
Patients will have completed all breast surgical procedures prior to accrual into this protocol in order to establish eligibility criteria. Final pathology margins must be at least 1 mm in all directions to be eligible. The patient may undergo re-excision if the initial margins are involved or close (< 1mm). If the patient meets the eligibility criteria after re-excision, she may be entered onto the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 Daily Boost of Radiation Therapy | Experimental | Arm 1 of treatment, you will be receiving 15 daily radiation fractions of 2.7 Gy (measure of radiation dose) daily for three weeks to the entire breast with a daily concomitant boost of 0.5 Gy |
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| Arm 2 Weekly Boost of Radiation Therapy | Experimental | Arm 2 Weekly Boost will receive 15 daily radiation fractions of 2.7 Gy for three weeks to the entire breast with a weekly boost of 2.0 GY. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arm 1 Daily Boost of Radiation Therapy | Radiation | Arm 1 Daily boost. IMRT at 2.7Gy x15 fractions. Total dose 40.50Gy. Daily Boost 0.5Gy to tumor bed x 15 fractions. Tumor Bed Total=48Gy |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with acute radiation toxicity of Grade 2 or higher. | By accruing 1000 patients randomized in strata defined by the two approaches to either weekly or daily boost, we will be able to establish the feasibility using different techniques and toxicity of prone breast radiotherapy with a weekly versus a daily boost, with IMRT and with 3DCRT non-IMRT approaches. | Up to 90 days of radiation treatment |
| Number of patients with late radiation toxicity. | By accruing 1000 patients randomized in strata defined by the two approaches to either weekly or daily boost, we will be able to establish the feasibility using different techniques and toxicity of prone breast radiotherapy with a weekly versus a daily boost, with IMRT and with 3DCRT non-IMRT approaches. | 90 days following radiation treatment up to 5years |
| Local Recurrence | To compare local control rates, distant recurrence and overall survival for weekly versus daily boost within strata defined by 3DCRT or IMRT at 2 and 5 year follow-up. | up to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carmen Perez, M.D., Ph.D. | NYU Langone Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Cancer Institute | New York | New York | 10016 | United States |
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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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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Arm 2 Weekly Boost of Radiation Therapy | Radiation | Arm2: IMRT at 2.7Gy x 15 fractions. Total Dose=40.50 Gy. Weekly Boost 2Gy (on Friday). Tumor Bed Total 46.50Gy |
|
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| D017437 |
| Skin and Connective Tissue Diseases |