Skip to main content
OpenTrials
Completed

NCT Number: NCT01000662

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Bellevue Hospital Center, New York, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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."

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Phase III Study Comparing Whole Breast Radiotherapy With a Daily Tumor Red Boost

Important dates

Study start
2009
Primary completion
2012
Study completion
2017
First posted
Oct 23, 2009
Registry last updated
Aug 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.