Clinical trial NCT01000662: Study Comparing Whole Breast Radiotherapy With a Daily Versus a Weekly Tumor
Official title: Phase III Study Comparing Whole Breast Radiotherapy With a Daily Tumor Red Boost
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: whole breast radiotherapy
tumor bed boost
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2009-10-23
Enrollment: 412
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Number of Participants With Acute Radiation Toxicities Recorded According to Radiation Therapy Oncology Group (RTOG)
timeFrame: Day 60
Secondary outcomes:
measure: Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at Baseline
timeFrame: Baseline
measure: Score on "SF-36 v2 Vitality" Scale
timeFrame: Baseline
measure: Average Score on Brief Pain Inventory (BPI) Scale
timeFrame: Baseline
measure: Average Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale
timeFrame: Baseline
measure: Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at the End of Treatment
timeFrame: At the end of Treatment, an average of 3 weeks
measure: Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS)
timeFrame: 45-60 days after treatment
measure: Score on "SF-36 v2 Vitality" Scale
timeFrame: End of Treatment
measure: Score on "SF-36 v2 Vitality" Scale 45-60 Days After Treatment
timeFrame: 45-60 days after treatment
measure: Average Score on Brief Pain Inventory (BPI)
timeFrame: At the end of Treatment, an average of 3 weeks
measure: Average Score on Brief Pain Inventory (BPI)
timeFrame: 45-60 days after treatment
measure: Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, at End of Treatment
timeFrame: End of Treatment
measure: Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale, 45-60 Days After Treatment
timeFrame: 45-60 days after treatment
Other outcomes:
Locations:
city: New York
country: United States
facility: Bellevue Hospital Center
state: New York
city: New York
country: United States
facility: NYU Clinical Cancer Center
state: New York
city: New York
country: United States
facility: Tisch Hospital
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Carmen Perez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cooper BT, Formenti-Ujlaki GF, Li X, Shin SM, Fenton-Kerimian M, Guth A, Roses DF, Hitchen CJ, Rosenstein BS, Dewyngaert JK, Goldberg JD, Formenti SC. Prospective Randomized Trial of Prone Accelerated Intensity Modulated Breast Radiation Therapy With a Daily Versus Weekly Boost to the Tumor Bed. Int J Radiat Oncol Biol Phys. 2016 Jun 1;95(2):571-8. doi: 10.1016/j.ijrobp.2015.12.373. Epub 2015 Dec 29.
citation: Garsa AA, Ferraro DJ, DeWees TA, Deshields TL, Margenthaler JA, Cyr AE, Naughton M, Aft R, Gillanders WE, Eberlein T, Matesa MA, Ochoa LL, Zoberi I. A prospective longitudinal clinical trial evaluating quality of life after breast-conserving surgery and high-dose-rate interstitial brachytherapy for early-stage breast cancer. Int J Radiat Oncol Biol Phys. 2013 Dec 1;87(5):1043-50. doi: 10.1016/j.ijrobp.2013.09.009. Epub 2013 Oct 22.
citation: Finkel MA, Cooper BT, Li X, Fenton-Kerimian M, Goldberg JD, Formenti SC. Quality of Life in Women Undergoing Breast Irradiation in a Randomized, Controlled Clinical Trial Evaluating Different Tumor Bed Boost Fractionations. Int J Radiat Oncol Biol Phys. 2016 Jun 1;95(2):579-89. doi: 10.1016/j.ijrobp.2016.02.004. Epub 2016 Feb 6.