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Prospective Trial of Two Prone Breast Radiotherapy Techniques With Randomization to Concurrent Versus Weekly Boost

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01591811
First Posted: May 4, 2012
Last Update Posted: July 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
New York University School of Medicine
  Purpose
  1. To test the hypothesis that when prone, patients treated with 3D-CRT breast radiotherapy and randomly assigned to either a weekly or a daily boost to the tumor bed develop acute toxicity that is not significantly worse than that of a concurrent cohort of patients treated with IMRT randomly assigned to a weekly or daily boost regimen.
  2. To test the hypothesis that when prone, patients treated with 3D-CRT breast radiotherapy, randomly assigned to either a weekly or a daily boost to the tumor bed develop late toxicity that is not significantly worse than that of concurrent cohort of patients treated with IMRT randomly assigned to a weekly of daily boost.
  3. To test hypothesis that 5 year local control rates of ≤ 5% in-breast recurrence can be achieved in each of the two randomized arms, for either technique tested.

Condition Intervention Phase
Breast Cancer Radiation: Arm 1 Daily Boost of Radiation Therapy Radiation: Arm 2 Weekly Boost of Radiation Therapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Trial of Two Prone Breast Radiotherapy Techniques With Randomization to Concurrent Versus Weekly Boost

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Number of patients with acute radiation toxicity of Grade 2 or higher. [ Time Frame: Up to 90 days of radiation treatment ]
    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.

  • Number of patients with late radiation toxicity. [ Time Frame: 90 days following radiation treatment up to 5years ]
    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.

  • Local Recurrence [ Time Frame: up to 5 years ]
    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.


Enrollment: 433
Study Start Date: April 2012
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Daily Boost of Radiation Therapy
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
Radiation: Arm 1 Daily Boost of Radiation Therapy
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
Other Name: Radiation Therapy
Experimental: Arm 2 Weekly Boost of Radiation Therapy
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.
Radiation: Arm 2 Weekly Boost of Radiation Therapy
Arm2: IMRT at 2.7Gy x 15 fractions. Total Dose=40.50 Gy. Weekly Boost 2Gy (on Friday). Tumor Bed Total 46.50Gy
Other Name: Radiotherapy

Detailed Description:

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.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pre- or post-menopausal women with Stage 0, I and II breast cancer (Post-menopausal women defined as either (a) at least 2 years without menstrual period or (b) or patients older than 50 with serological evidence of post-menopausal status or (c) hysterectomized patients of any age with FSH confirmation of post-menopausal status)
  2. Biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm
  3. Status post segmental mastectomy, after sentinel node biopsy and/or axillary node dissection (DCIS and Tumors <5 mm in size do not require nodal assessment)
  4. At least 2 weeks from last chemotherapy
  5. Patient needs to be able to understand and demonstrate willingness to sign a written informed consent document

Exclusion Criteria:

  1. Previous radiation therapy to the ipsilateral breast
  2. More than 3 involved nodes identified at axillary staging, requiring adjuvant axillary radiation
  3. Active connective tissue disorders, such as lupus or scleroderma
  4. Prior or concurrent malignancy other than basal or squamous cell skin cancer or carcinoma in-situ of the cervix, unless disease-free > 3 years
  5. Pregnant or lactating women
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01591811


Locations
United States, New York
NYU Cancer Institute
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Carmen Perez, M.D., Ph.D. NYU Langone Medical Center
  More Information

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01591811     History of Changes
Other Study ID Numbers: 12-01299
First Submitted: April 26, 2012
First Posted: May 4, 2012
Last Update Posted: July 21, 2017
Last Verified: July 2017