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

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.
 
ClinicalTrials.gov Identifier: NCT01000662
Recruitment Status : Completed
First Posted : October 23, 2009
Results First Posted : May 29, 2015
Last Update Posted : August 6, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: Daily Radiation Therapy Radiation: Weekly Radiation Therapy Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 412 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase III Study Comparing Whole Breast Radiotherapy With a Daily Tumor Red Boost
Study Start Date : March 2009
Actual Primary Completion Date : July 2012
Actual Study Completion Date : June 14, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ARM 1 daily boost
Radiation Therapy
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.

Active Comparator: ARM 2 weekly boost
Radiation Therapy
Radiation: 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.




Primary Outcome Measures :
  1. Number of Participants With Acute Radiation Toxicities Recorded According to Radiation Therapy Oncology Group (RTOG) [ Time Frame: Day 60 ]
    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


Secondary Outcome Measures :
  1. Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at Baseline [ Time Frame: 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.


  2. Score on "SF-36 v2 Vitality" Scale [ Time Frame: Baseline ]
    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".

  3. Average Score on Brief Pain Inventory (BPI) Scale [ Time Frame: Baseline ]

    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.


  4. Average Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale [ Time Frame: Baseline ]
    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.

  5. Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at the End of Treatment [ Time Frame: At the end of Treatment, an average of 3 weeks ]

    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.


  6. Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) [ Time Frame: 45-60 days after 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.


  7. Score on "SF-36 v2 Vitality" Scale [ Time Frame: End of 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".

  8. Score on "SF-36 v2 Vitality" Scale 45-60 Days After Treatment [ Time Frame: 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".

  9. Average Score on Brief Pain Inventory (BPI) [ Time Frame: At the end of Treatment, an average of 3 weeks ]

    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.


  10. Average Score on Brief Pain Inventory (BPI) [ Time Frame: 45-60 days after treatment ]

    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.


  11. Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, at End of Treatment [ Time Frame: End of Treatment ]
    4 levels: 1 = "Excellent"; 2 = "Good"; 3 = "Fair"; 4 = "Poor"

  12. Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, 45-60 Days After Treatment [ Time Frame: 45-60 days after treatment ]
    4 levels: 1 = "Excellent"; 2 = "Good"; 3 = "Fair"; 4 = "Poor."



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

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): NCT01000662


Locations
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United States, New York
Bellevue Hospital Center
New York, New York, United States, 10016
NYU Clinical Cancer Center
New York, New York, United States, 10016
Tisch Hospital
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Carmen Perez, MD NYU School of Medicine
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT01000662    
Other Study ID Numbers: 09-0030
First Posted: October 23, 2009    Key Record Dates
Results First Posted: May 29, 2015
Last Update Posted: August 6, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by NYU Langone Health:
whole breast radiotherapy
tumor bed boost