Clinical trial · Interventional
Prospective Randomized Study of Accelerated Radiation Therapy (PRART)
Prospective Randomized Study of Accelerated Radiation Therapy (PRART) : A Non-Inferiority Trial to Compare Breast Cosmesis and Local Control After Concomitant Boost Breast Radiotherapy With Fifteen Fractions in Three Weeks (Arm 1, Standard) Versus Ten Fractions in Two Weeks (Arm 2, Experimental)
- 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)
Patients with Stage 0 ductal carcinoma in situ (Tis (DCIS), Stage T1-T2, lymph node negative(N0) breast cancers will be randomized to receive whole breast radiotherapy with a concomitant boost to the tumor bed over 15 fractions (Arm 1, standard) versus 10 fractions (Arm 2, experimental).
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 - 2 weeks | Radiation | — | UNRESOLVED |
| Radiation therapy - 3 weeks | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ARM 1-4050cGY and boost to tumor bed of 4800cGY in 15fractions
- description
- Patients randomized to ARM 1 will receive whole breast radiotherapy of 4050cGY and a concomitant boost to the tumor bed of 4800cGY in 15 fractions
- interventionNames
- Radiation: Radiation therapy - 3 weeks
- type
- EXPERIMENTAL
- label
- ARM 2 - 3200cGY and boost to tumor bed of 4200cGY -10fractions
- description
- Patients randomized to ARM 2 will receive whole breast radiotherapy of 3200cGY and a concomitant boost to the tumor bed of 4200cGY in 10 fractions.
- interventionNames
- Radiation: Radiation therapy - 2 weeks
Primary outcomes (1)
- measure
- Proportion of Patients With Acute Toxicity Grade ≥ 2 on the 10-fraction Arm Compared to Proportion of Patients With Acute Toxicity Grade ≥ 2 on the 15-fraction Arm Evaluated up to 1-month Post-radiation Treatment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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 or pN0 or sentinel node negative * Ductal carcinoma in situ DCIS with negative margins (no DCIS on inked margins). * Women with previous contralateral breast cancer. 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
References
Publications (0)
Data not yet available