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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
department of radiation oncology
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01000662
First received: October 9, 2009
Last updated: June 1, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Radiation: Radiation therapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Study Comparing Whole Breast Radiotherapy With a Daily Versus a Weekly Tumor

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Acute radiation toxicities recorded according to RTOG [ Time Frame: Day 1 of radiation treatment to day 60 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • QOL (Quality of Life) questionnaire of patients on the 2 different arms of treatment [ Time Frame: at baseline, at the end of last week of treatment, and at 2 year Follow-up ] [ Designated as safety issue: No ]
  • Late radiation toxicities recorded according to LENT/SOMA [ Time Frame: yearly for five years after completion of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: March 2009
Estimated Study Completion Date: March 2022
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ARM 1 daily boost Radiation: 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.
Active Comparator: ARM 2 weekly boost Radiation: 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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01000662

Locations
United States, New York
NYU Clinical Cancer Center
New York, New York, United States, 10016
Tisch Hospital
New York, New York, United States, 10016
Bellevue Hospital Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
department of radiation oncology
  More Information

No publications provided

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01000662     History of Changes
Other Study ID Numbers: 09-0030
Study First Received: October 9, 2009
Last Updated: June 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
whole breast radiotherapy
tumor bed boost

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013