Actively Recruiting
Randomized Phase III Trial Testing Maintenance Olaparib Versus Observation After Adjuvant Chemoradiation for p53abn Endometrial Cancer
Led by Gustave Roussy, Cancer Campus, Grand Paris · Updated on 2026-01-20
554
Participants Needed
15
Research Sites
387 weeks
Total Duration
On this page
Sponsors
G
Gustave Roussy, Cancer Campus, Grand Paris
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Randomized Phase III Trial Testing Maintenance Olaparib Versus Observation After Adjuvant Chemoradiation for p53abn Endometrial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of endometrial cancer, including endometrioid, serous, clear cell, de-/undifferentiated carcinomas, and uterine carcinosarcoma
- Molecular classification performed according to WHO 2020 guidelines
- Total hysterectomy with bilateral salpingo-oophorectomy (TLH-BSO or TAH-BSO) with or without lymphadenectomy or sentinel node biopsy, with no visible residual disease after surgery
- No distant metastases as confirmed by pre- or post-surgical imaging (CT or PET-CT)
- Written informed consent obtained
- Age 18 years or older
- Life expectancy of at least 16 weeks
- Accessible for treatment and follow-up
- WHO Performance score 0-1
- Stage I to III endometrial cancer with myometrial invasion
- p53 abnormal molecular classification with pMMR and POLE wildtype or non-pathogenic status
- Body weight over 30 kg
- Received or scheduled to receive sequential radiotherapy and chemotherapy preferably following PORTEC-3 regimen within 6 to 8 weeks post-surgery, no later than 10 weeks
- Adequate organ and bone marrow function within 28 days prior to study treatment
- Affiliated with a social security system or equivalent
- Able and willing to comply with study visits and procedures
You will not qualify if you...
- FIGO Stage IV disease of any histology
- Prior pelvic irradiation
- Other malignancies unless cured with no evidence for 5 years except certain treated skin or cervical cancers and low-grade endometrial carcinoma
- Uncontrolled or reversible cardiac conditions or congenital long QT syndrome
- Persistent toxicities from previous cancer therapy above grade 2 (excluding alopecia)
- Immunocompromised status including HIV positive
- Chemotherapy or radiotherapy within 3 weeks prior to study treatment (except palliative)
- Poor medical risk due to serious uncontrolled disorders or infections
- Major surgery within 2 weeks prior to randomization
- Significant traumatic injury within 4 weeks before starting Olaparib
- History of allogenic organ transplant
- Active uncontrolled illnesses including infections, heart failure, hypertension, or psychiatric disorders limiting consent or compliance
- Severe liver impairment
- Previous treatment with PARP inhibitors including Olaparib
- History of active primary immunodeficiency
- Hemorrhagic disorders within 6 months prior to randomization
- History or signs of myelodysplastic syndrome or acute myeloid leukemia
- Previous allogenic bone marrow transplant or double umbilical cord blood transplantation
- Active infections including tuberculosis, hepatitis B or C, or HIV (with some exceptions for past resolved infections)
- Use of strong or moderate CYP3A inhibitors or inducers without required washout period
- Inability to swallow oral medication or gastrointestinal disorders affecting absorption
- Medical or psychological conditions preventing study completion or informed consent
- Under guardianship or deprived of liberty
- Known allergy to Olaparib or its ingredients
- Treatment with unlicensed or investigational products within 4 weeks prior
- Breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Centre Hospitalier D'Albi
Albi, France, 81000
Actively Recruiting
2
Institut Cancerologie de L'Ouest-Angers
Angers, France, 49055
Actively Recruiting
3
Chu Besancon
Besançon, France, 25030
Actively Recruiting
4
Centre Hospitalier de Carcassonne
Carcassonne, France, 11000
Actively Recruiting
5
Chu Dijon
Dijon, France, 21000
Actively Recruiting
6
Groupe Hospitalier Mutualiste de Grenoble
Grenoble, France, 38000
Not Yet Recruiting
7
CHU De LIMOGES
Limoges, France, 87000
Actively Recruiting
8
Centre LEON BERARD
Lyon, France, 69008
Actively Recruiting
9
Institut Paoli Calmettes
Marseille, France, 13009
Actively Recruiting
10
Centre Antoine LACASSAGNE
Nice, France, 06189
Actively Recruiting
11
Institut Marie-Curie
Paris, France, 75005
Actively Recruiting
12
Hopital Cochin
Paris, France, 75014
Not Yet Recruiting
13
INSTITUT CANCEROLOGIE DE L'OUEST-St HERBLAIN
Saint-Herblain, France, 44800
Actively Recruiting
14
Clinique Sainte Anne
Strasbourg, France, 67000
Actively Recruiting
15
Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
Research Team
A
Alexandra Leary, MD, PhD
CONTACT
F
Flora NGADJEUA TCHOUATIEU, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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