NCT05640999 Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endometrial Cancer RAINBO BLUE & TAPER
| NCT ID | NCT05640999 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Canadian Cancer Trials Group |
| Condition | Endometrial Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 393 participants |
| Start Date | 2022-12-19 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 393 participants in total. It began in 2022-12-19 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: * 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.
Contact & Investigator
Kathy Han
STUDY CHAIR
University Health Network, Princess Margaret Hospital, Toronto ON Canada
Frequently Asked Questions
Who can join the NCT05640999 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Endometrial Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05640999 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05640999 currently recruiting?
Yes, NCT05640999 is actively recruiting participants. Contact the research team at wparulekar@ctg.queensu.ca for enrollment information.
Where is the NCT05640999 trial being conducted?
This trial is being conducted at Anchorage, United States, Tucson, United States, Los Angeles, United States, Pasadena, United States and 11 additional locations.
Who is sponsoring the NCT05640999 clinical trial?
NCT05640999 is sponsored by Canadian Cancer Trials Group. The principal investigator is Kathy Han at University Health Network, Princess Margaret Hospital, Toronto ON Canada. The trial plans to enroll 393 participants.
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