Prospective Randomized Trial of Two Versus One Week Accelerated Radiotherapy (PRATO)
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 400
- Locations
- 6
- Primary Endpoint
- Rate of RT-related acute toxicity
Study Overview
Brief Summary
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.
Detailed Description
Radiotherapy: one week (Arm 1) 2600 cGy in 5 fractions whole breast radiotherapy over one week versus 2 weeks (Arm 2), 3200 cGy in 10 fractions with a concomitant tumor bed boost to 3600 cGy. 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.
Hypothesis
A regimen of whole breast radiotherapy to 2600 in five fractions, the current UK standard for early breast cancer (Arm 2), is not inferior to 3200cGy with a concomitant tumor bed boost to 3600 cGy in 10 fractions (Arm 1), in terms of acute toxicity and long-term fibrosis, breast cosmesis and local control at 2 and 5 years. It will also test the hypothesis of superior local control at 10 years in Arm 2 compared to Arm 1.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •Ductal carcinoma in situ DCIS with negative margins (no DCIS on inked margins).
- •Women with previous contralateral treated breast cancer can be enrolled in the trial.
Exclusion Criteria
- •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.
- •Ongoing treatment for severe autoimmune disease.
Arms & Interventions
ARM 1-2600 cGy in 5 fractions whole breast radiotherapy
Patients randomized to ARM 1 will receive 2600 cGy in 5 fractions whole breast radiotherapy over one week
Intervention: Radiation therapy - 1 week (Radiation)
ARM 2- 3200 cGy in 10 fractions with a concomitant tumor bed boost to 3600 cGy
Patients randomized to ARM 2 will receive 3200 cGy in 10 fractions with a concomitant tumor bed boost to 3600 cGy.
Intervention: Radiation therapy - 2 weeks (Radiation)
Outcomes
Primary Outcomes
Rate of RT-related acute toxicity
Time Frame: 1 month
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.
Secondary Outcomes
- The long-term evaluations at 2 years of fibrosis based on LENT/SOMA(24 months)
- The long-term evaluations at 2 years of breast cosmesis(24 months)
- The long-term evaluations at 2 years of local control(24 months)
- The long-term evaluations at 5 years OF fibrosis based on LENT/SOMA(60 months)
- The long-term evaluations at 5 years of breast cosmesis(60 months)
- The long-term evaluations at 5 years of local control.(60 months)
- Superior local control at 10 years(120 months)