Informations générales (source: ClinicalTrials.gov)
A Phase II Study of Tailored Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endormetrial Cancer (RAINBO BLUE & TAPER)
Interventional
Phase 2
Canadian Cancer Trials Group (Voir sur ClinicalTrials)
décembre 2022
juin 2029
07 octobre 2026
This protocol tests de-escalated adjuvant treatment in patients with POLE-mutated or
p53wt/NSMP (p53 wildtype/no specific molecular profile) early-stage endometrial cancer
(EC). Patients may be enrolled in one of two sub-studies
- EN10.A/RAINBO BLUE: POLE-mutated EC
- EN10.B/TAPER: p53 wildtype / NSMP EC
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Alexandra LEARY | 06/10/2026 19:10:38 | Contacter | ||
Critères
Femme
- Patients must have had surgery consisting of hysterectomy and bilateral
salpingo-oophorectomy. Lymph node dissection can be performed as per institutional
standards. There must be no macroscopic residual disease after surgery.
- Patients must have histologically confirmed Stage I to III endometrial carcinoma
which can be endometrioid, serous, clear cell, un/dedifferentiated, carcinosarcoma
or mixed.
- Patients' Eastern Cooperative Group (ECOG) performance status must be 0, 1, or 2.
- HIV-infected patients on effective anti-retroviral therapy with undetectable viral
load within 6 months are eligible for this trial.
- Patients' age must be ≥ 18 years.
- Patient consent must be appropriately obtained in accordance with applicable local
and regulatory requirements.
- Patient is able (i.e. sufficiently fluent) and willing to complete the
patient-reported outcomes (PRO) questionnaires in either English, French or a
validated language
- Patients must be accessible for treatment and follow-up. Patients enrolled on this
trial must be treated and followed at the participating centre
- Protocol treatment is to begin within 10 weeks of hysterectomy/bilateral
salpingo-oophorectomy
Exclusion Criteria:
- Prior Neoadjuvant chemotherapy for current endometrial cancer diagnosis.
- Prior pelvic radiation.
- Patients with a history of other malignancies, except: carcinoma in-situ without
evidence of invasive disease when resected, adequately treated non-melanoma skin
cancer, or other tumours curatively treated with no evidence of disease for ≥ 5
years.
- Clinical evidence of distant metastasis as determined by pre-surgical or
post-surgical imaging (CT scan of chest, abdomen and pelvis or whole-body PET-CT
scan)
- Patients with a documented positive surgical margin.
- Patients with a documented positive peritoneal washings, if performed.