RecruitingPhase 3NCT06712472

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


Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Enrollment

554 participants

Start Date

Jun 26, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase III trial tests whether the targeted drug olaparib (a PARP inhibitor) given after chemoradiation is more effective than observation alone in preventing recurrence in patients with a high-risk molecular subtype of endometrial (uterine) cancer called p53-abnormal. **You may be eligible if...** - You have histologically confirmed endometrial cancer (any grade; including endometrioid, serous, clear cell, undifferentiated, or uterine carcinosarcoma) - Your tumor has been classified as the p53-abnormal molecular subtype - You had surgery to remove the uterus (with or without lymph node removal) with no visible remaining cancer - You have no distant spread confirmed by imaging - You are 18 or older with a life expectancy of at least 16 weeks **You may NOT be eligible if...** - Distant metastases are found before or after surgery - Your tumor does not fall into the required molecular classification - You cannot receive the required chemoradiation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOlaparib (300 mg BID)

Olaparib 300mg Bid during one year.


Locations(15)

Centre Hospitalier D'Albi

Albi, France

Institut Cancerologie de L'Ouest-Angers

Angers, France

Chu Besancon

Besançon, France

Centre Hospitalier de Carcassonne

Carcassonne, France

Chu Dijon

Dijon, France

Groupe Hospitalier Mutualiste de Grenoble

Grenoble, France

CHU De LIMOGES

Limoges, France

Centre LEON BERARD

Lyon, France

Institut Paoli Calmettes

Marseille, France

Centre Antoine LACASSAGNE

Nice, France

Institut Marie-Curie

Paris, France

Hopital Cochin

Paris, France

INSTITUT CANCEROLOGIE DE L'OUEST-St HERBLAIN

Saint-Herblain, France

Clinique Sainte Anne

Strasbourg, France

Gustave Roussy

Villejuif, France

View Full Details on ClinicalTrials.gov

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NCT06712472


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