Randomized Phase III Trial Testing Maintenance Olaparib Versus Observation After Adjuvant Chemoradiation for p53abn Endometrial Cancer
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Study ID
- NCT06712472
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Endometrial Cancer
- p53abn
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Olaparib (300 mg BID) — DRUGOlaparib 300mg Bid during one year.
Study Details
The RAINBO program is a studies group which proposes personalized treatment of patients suffering from endometrial cancer according to their molecular profile. the RAINBO-RED study allows observation or maintenance treatment with targeted therapy for one year (olaparib). This after standard therapy. The goal is to improve recurrence-free survival of patients treated with Olaparib.
Key Dates
- Start date
- Jun 26, 2024
- Status verified
- Jan 2026
- Primary completion
- Jun 30, 2030
- Completion
- Dec 31, 2031
Study Design
- Enrollment
- 554 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- No Intervention: Standard arm
- Experimental: Experimental arm
Primary Outcome Measure
Recurrence-Free survival [ Time Frame: 3 years ]
Central Contacts
- Alexandra Leary, MD, PhD+33 1 42 11 42 11
- Flora NGADJEUA TCHOUATIEU, PhD+33 1 42 11 42 11
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