Two Versus One Week Breast Radiotherapy (RT)
ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorWeill Medical College of Cornell University
About this trial
This study is comparing two different radiation therapy approaches for early breast cancer to see which one is better for patients. One group will receive radiation over one week (based on the FAST-FORWARD trial), and the other group will receive radiation over two weeks with an extra focused dose (called a "concomitant boost"). The study will look at how the treatments affect side effects, breast appearance, and cancer control in the breast. It also aims to find out if the two-week treatment does a better job at preventing cancer from coming back in the breast over the long term.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women status post segmental mastectomy.
If unilateral, pT1-2 breast cancer excised with negative margins.
If bilateral, pT1-2 breast cancer excised with negative margins AND/OR pTis excised with negative margins.
Clinically N0 (cN0 as determined by ultrasound/SOUND criteria) or pN0-1 or Nx or sentinel node negative.
Disqualifiers
Previous radiation therapy to the ipsilateral breast.
>90 days from last surgery, unless s/p adjuvant chemotherapy.
>60 days from last chemotherapy.
Male breast cancer.
Trial design
Design model
Parallel
Treatments tested in this trial
Radiation therapy - 1 week
Radiation2600 cGy whole breast radiotherapy in five fractions (Arm 1) over 1 week
Radiation therapy - 2 weeks
Radiation3200 cGy whole breast radiotherapy with a concomitant tumor bed boost to 3600 cGy in 10 fractions (Arm 2) over 2 weeks. In Arm 2, if no cavity is visible due to oncoplastic surgery, we will deliver 32 Gy to the whole breast only, without a boost.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: ARM 1-2600 cGy in 5 fractions whole breast radiotherapyExperimental treatment 1 intervention
Group B: ARM 2- 3200 cGy in 10 fractions with a concomitant tumor bed boost to 3600 cGyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of RT-related acute toxicity
The rate of RT-related acute toxicity is defined as cumulative acute toxicity events from the start of radiation treatment to 1 month follow up post RT. The toxicities will be graded by the research nurses assigned to the study according to Common Terminology Criteria for Adverse Events, version 5.0.
Time frame
1 monthSecondary outcomes
1
The long-term evaluations at 2 years of fibrosis based on LENT/SOMA
The number of subjects scoring Grades 1 through 4 using the LENT/SOMA (Late Effects Normal Tissues (LENT)-Subjective, Objective, Management, Analytic (SOMA)) system will be reported. The patients will grade the following items based on the following scale: 1. Mild 2. Moderate 3. Severe 4. Life-threatening
Time frame
24 months2
The long-term evaluations at 2 years of breast cosmesis
Patient self-reported breast cosmesis will be assessed using the BCTOS questionnaire (Breast Cancer Treatment Outcome Scale).The number of subjects scoring Grades 1 through 4 will be reported. The patients will grade the following items based on the following scale: 1. = No difference between treated and untreated breast/area 2. = Slight difference 3. = Moderate difference 4. = Large difference
Time frame
24 months3
The long-term evaluations at 2 years of local control
Number of subjects with Local control at 2 years will be extracted from the medical record, and can be derived from clinical reports from medical, surgical or radiation oncologists as well as from the primary care doctor who is following the patient.
Time frame
24 months4
The long-term evaluations at 5 years OF fibrosis based on LENT/SOMA
The number of subjects scoring Grades 1 through 4 using the LENT/SOMA (Late Effects Normal Tissues (LENT)-Subjective, Objective, Management, Analytic (SOMA)) system will be reported. The patients will grade the following items based on the following scale: 1. Mild 2. Moderate 3. Severe 4. Life-threatening
Time frame
60 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov