Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endometrial Cancer RAINBO BLUE & TAPER

What this study is about

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

Who can join (things the study team will check)

✅ You may be able to join if…

• 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

🚫 You may not be able to join if…

• 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.

Where this trial is running

• Alaska Womens Cancer Care, Anchorage, Alaska, United States
• University of Arizona Cancer Center, Tucson, Arizona, United States
• Cedars-Sinai Medical Center, Los Angeles, California, United States
• Huntington Memorial Hospital, Pasadena, California, United States
• Sutter Medical Center Sacramento, Sacramento, California, United States
• UCHealth University of Colorado Hospital, Aurora, Colorado, United States
• AdventHealth Porter, Denver, Colorado, United States
• University of Miami School of Medicine, Miami, Florida, United States
• Sarasota Memorial Hospital - Venice, N. Venice, Florida, United States
• Florida Cancer Specialists - Sarasota Downtown, Sarasota, Florida, United States
• First Physicians Group-Sarasota, Sarasota, Florida, United States
• Sarasota Memorial Hospital, Sarasota, Florida, United States

+ 98 more sites.

Who to contact

Wendy Parulekar · 613-533-6430 · wparulekar@ctg.queensu.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05640999.