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Refining Adjuvant treatment IN endometrial cancer Based On molecular features, TransPORTEC platform trials – p53abn - RED (RAINBO-p53abnRED) Randomized phase III trial testing maintenance olaparib versus observation after adjuvant chemoradiation for p53abn endometrial cancer

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503886-44-00
Acronym
CSET 2023/3603
Enrollment
150
Registered
2023-12-12
Start date
2024-06-10
Completion date
Unknown
Last updated
2025-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

after surgery (hysterectomy and bilateral salpingooophorectomy, Patients with a histological diagnosis of p53abn HREC, treated with curative intent, with or without lymphadenectomy or sentinel node biopsy), without signs of residual disease or distant metastases

Brief summary

Recurrence free survival (RFS) in patients with p53abn EC, as assessed by the investigator. RFS is defined as time from randomization until date of any recurrence (local or distant) or date of death due to any cause

Detailed description

Overall survival (OS) ,Disease-specific survival , Vaginal recurrence-free survival , Pelvic recurrence-free survival , Distant recurrence-free survival

Interventions

DRUGLynparza 100 mg film-coated tablets
DRUGLynparza 150 mg film-coated tablets

Sponsors

Institut Gustave Roussy
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Recurrence free survival (RFS) in patients with p53abn EC, as assessed by the investigator. RFS is defined as time from randomization until date of any recurrence (local or distant) or date of death due to any cause

Secondary

MeasureTime frame
Overall survival (OS) ,Disease-specific survival , Vaginal recurrence-free survival , Pelvic recurrence-free survival , Distant recurrence-free survival

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026