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

NCT06712472 | Recruiting Phase 3 DMC

• 2 other identifiers: 2023-503886-44-002023/3603
• Study Type: interventional
• Target: 554
• Locations: 1 country
• Sites: 15

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.

Conditions

Endometrial Cancer; p53abn

Outcome Measures

Primary Outcomes (1)

• Recurrence-Free survival

  To assess whether maintenance therapy with olaparib improves recurrence-free survival (RFS), as compared to observation after chemo-radiotherapy in patients with p53abn HREC

  3 years

Study Arms (2)

Standard arm

NO INTERVENTION

Experimental arm

EXPERIMENTAL

Drug: Olaparib (300 mg BID)

Interventions

Olaparib (300 mg BID) DRUG

Olaparib 300mg Bid during one year.

Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• This may include;

You may not qualify if:

• FIGO Stage IV disease of any histology even if there is no evidence of disease after surgery
• Prior pelvic irradiation
• Other malignancy unless curatively treated with no evidence of disease for ≥5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma.
• Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (eg., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation \>500 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome.
• Persistent toxicities (\>Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia.
• Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV).
• Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment
• Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent.
• Major surgical procedure (as defined by the Investigator) within 2 weeks prior randomization and patients must have recovered from any effects of any major surgery.
• Significant traumatic injury within 4 weeks of the first dose of olaparib.
• History of allogenic organ transplantation.
• Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
• Patient with severe hepatic impairment
• Any previous treatment with a PARP inhibitor, including olaparib.
• History of active primary immunodeficiency

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead
• AstraZeneca: collaborator

Study Sites (15)

Centre Hospitalier D'Albi

Albi, 81000, France

RECRUITING

Institut Cancerologie de L'Ouest-Angers

Angers, 49055, France

RECRUITING

Chu Besancon

Besançon, 25030, France

RECRUITING

Centre Hospitalier de Carcassonne

Carcassonne, 11000, France

RECRUITING

Chu Dijon

Dijon, 21000, France

RECRUITING

Groupe Hospitalier Mutualiste de Grenoble

Grenoble, 38000, France

NOT YET RECRUITING

CHU De LIMOGES

Limoges, 87000, France

RECRUITING

Centre LEON BERARD

Lyon, 69008, France

RECRUITING

Institut Paoli Calmettes

Marseille, 13009, France

RECRUITING

Centre Antoine LACASSAGNE

Nice, 06189, France

RECRUITING

Institut Marie-Curie

Paris, 75005, France

RECRUITING

Hopital Cochin

Paris, 75014, France

NOT YET RECRUITING

INSTITUT CANCEROLOGIE DE L'OUEST-St HERBLAIN

Saint-Herblain, 44800, France

RECRUITING

Clinique Sainte Anne

Strasbourg, 67000, France

RECRUITING

Gustave Roussy

Villejuif, 94805, France

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

olaparib; BID protein, human

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Alexandra Leary, MD, PhD

CONTACT

+33 1 42 11 42 11; Alexandra.LEARY@gustaveroussy.fr

Flora NGADJEUA TCHOUATIEU, PhD

CONTACT

+33 1 42 11 42 11; Flora.NGADJEUA-TCHOUATIEU@gustaveroussy.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 2, 2024
• Study Start: June 26, 2024
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): December 1, 2031
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (15)