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Randomized Phase III Trial Testing Maintenance Olaparib Versus Observation After Adjuvant Chemoradiation for p53abn Endometrial Cancer

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
ClinicalTrials.gov
Registry ID
NCT06712472
Acronym
RAINBO-RED
Enrollment
554
Registered
2024-12-02
Start date
2024-06-26
Completion date
2031-12-01
Last updated
2026-01-20

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

Conditions

Endometrial Cancer, p53abn

Brief summary

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.

Interventions

Olaparib 300mg Bid during one year.

Sponsors

Gustave Roussy, Cancer Campus, Grand Paris
Lead SponsorOTHER
AstraZeneca
CollaboratorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Key inclusion criteria for RAINBO program: * Histologically confirmed diagnosis of EC (all grades and the following histologic subtypes : endometrioid, serous, clear cell, de-/undifferentiated carcinomas, and uterine carcinosarcoma). * Molecular classification performed following the diagnostic algorithm described in WHO 2020 (adapted from Vermij et al.) * TLH-BSO or TAH-BSO with or without lymphadenectomy or sentinel node biopsy, without macroscopic residual disease after surgery * No distant metastases as determined by pre-surgical or post-surgical imaging (CT scan of chest, abdomen and pelvis or PET-CT scan) * Written informed consent prior to any study specific procedures * Age \>= 18 years * Patients must have a life expectancy ≥ 16 weeks * Patients must be accessible for treatment and follow-up * Written informed consent for one of the RAINBO trials and the overarching research project according to the local Ethics Committee requirements. Inclusion criteria specific for p53abn-RED Trial: * WHO Performance score 0-1 * Histologically confirmed Stage I to III EC with myometrial invasion * Molecular classification: p53abn EC\* * Body weight \> 30 kg * Patient must receive or have received a sequential radiotherapy and chemotherapy preferably given according to the PORTEC-3 regimen and should be started within 6 to 8 weeks after surgery and no later than 10 weeks: two cycles of intravenous cisplatin 50mg/m² in the first and fourth week of the pelvic external beam radiotherapy (EBRT) +/- vaginal brachytherapy followed by four cycles of intravenous carboplatin AUC 5 and paclitaxel 175 mg/m² at 21-day intervals. However the sequence of chemotherapy , number of cycles and inclusion of cisplatin may be altered according to local practice at the investigator's discretion. This may include; * 4 cycles carboplatin \& paclitaxel before or after radiotherapy with 2 cycles cisplatin * 4 cycles carboplatin \& paclitaxel before or after radiotherapy (no cisplatin) * 6 cycles carboplatin \& paclitaxel before or after radiotherapy (no cisplatin) * Patients registered after their standard treatment must: * provide a tumor assessment performed within the 4 weeks before the start of RT/CT. This will be considered as the M0. * have started RT/CT 6 to 8 weeks after surgery. A maximum gap of 10 weeks is accepted. * be randomized within two weeks before maintenance or observation. * Adequate systemic organ function: Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below: * Creatinine clearance (\> 50 cc/min): Patients must have creatinine less than 1.5 ULN or calculated creatinine clearance estimated of ≥ 51 mL/min using the Cockcroft-Gault equation or based on a 24 hour urine test. Estimated creatinine clearance = (140-age \[years\]) x weight (kg) (x F) / serum creatinine (mg/dL) x 72 * Adequate bone marrow function : hemoglobin ≥10.0 g/dl with no blood transfusion in the past 28 days, Absolute neutrophil count (ANC) ≥1.5 x 109/l, platelet count ≥ 100 x 109/l. * Adequate liver function: bilirubin ≤1.5 x institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician. * ALT (SGPT) and/or AST (SGOT) ≤2.5 x ULN * \*Molecular classification must be performed according to the diagnostic algorithm presented in the WHO 2020 (Vermij et al. 2020). For the p53abn-RED trial this means that MMR and POLE status must be determined, and must be pMMR and POLE wildtype (or non-pathogenic) for inclusion. For details on the molecular classification see 7.1: Diagnostic algorithm for molecular classification. * Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol. * Patients must be affiliated to a social security system or beneficiary of the same

Design outcomes

Primary

MeasureTime frameDescription
Recurrence-Free survival3 yearsTo assess whether maintenance therapy with olaparib improves recurrence-free survival (RFS), as compared to observation after chemo-radiotherapy in patients with p53abn HREC

Countries

France

Contacts

CONTACTAlexandra Leary, MD, PhD
Alexandra.LEARY@gustaveroussy.fr+33 1 42 11 42 11
CONTACTFlora NGADJEUA TCHOUATIEU, PhD
Flora.NGADJEUA-TCHOUATIEU@gustaveroussy.fr+33 1 42 11 42 11

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026