Clinical trial · Interventional
Two Versus One Week Breast Radiotherapy (RT)
Prospective Randomized Trial of Two Versus One Week Accelerated Radiotherapy (PRATO)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation therapy - 1 week | Radiation | — | UNRESOLVED |
| Radiation therapy - 2 weeks | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ARM 1-2600 cGy in 5 fractions whole breast radiotherapy
- description
- Patients randomized to ARM 1 will receive 2600 cGy in 5 fractions whole breast radiotherapy over one week
- interventionNames
- Radiation: Radiation therapy - 1 week
- type
- EXPERIMENTAL
- label
- ARM 2- 3200 cGy in 10 fractions with a concomitant tumor bed boost to 3600 cGy
- description
- Patients randomized to ARM 2 will receive 3200 cGy in 10 fractions with a concomitant tumor bed boost to 3600 cGy.
- interventionNames
- Radiation: Radiation therapy - 2 weeks
Primary outcomes (1)
- measure
- Rate of RT-related acute toxicity
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: 1. Women status post segmental mastectomy. 2. If unilateral, pT1-2 breast cancer excised with negative margins. 3. If bilateral, pT1-2 breast cancer excised with negative margins AND/OR pTis excised with negative margins. 4. Clinically N0 (cN0 as determined by ultrasound/SOUND criteria) or pN0-1 or Nx or sentinel node negative. 5. Ductal carcinoma in situ DCIS with negative margins (no DCIS on inked margins). 6. Women with previous contralateral treated breast cancer can be enrolled in the trial. Exclusion Criteria: 1. Previous radiation therapy to the ipsilateral breast. 2. \>90 days from last surgery, unless s/p adjuvant chemotherapy. 3. \>60 days from last chemotherapy. 4. Male breast cancer. 5. Ongoing treatment for severe autoimmune disease.
References
Publications (0)
Data not yet available