NCT05640999

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

A Phase II Study of Tailored Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endormetrial Cancer (RAINBO BLUE & TAPER)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 393 (estimated)
• Sponsor: Canadian Cancer Trials Group · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

This study is being done in order to find out if this new approach is better or worse than the usual approach for early-stage endometrial cancer. The usual approach is defined as the care most people get for early-stage endometrial cancer. The usual approach for patients who are not in a study is treatment with surgery. Tissue that is removed as part of this procedure is analyzed in the pathology laboratory to guide the doctor to decide whether or not additional treatment such as radiation and or chemotherapy should be recommended.

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
RADIATION	Vaginal brachytherapy	Vaginal brachytherapy should be delivered using a vaginal cylinder, or alternatively ovoids
RADIATION	Adjuvant radiotherapy (EBRT +/- brachytherapy)	Treatment is to be delivered using 4-18 MV photons. MV, kV or CBCT imaging capabilities are required. Planning systems with capability for DICOM data transfer must be used.
OTHER	Observation	Observation

Timeline

• Start date: 2022-12-19
• Primary completion: 2028-12-31
• Completion: 2029-06-30
• First posted: 2022-12-07
• Last updated: 2026-04-14

Locations

105 sites across 8 countries: United States, Australia, Canada, France, Italy, Netherlands, New Zealand, Norway

Regulatory

• FDA-regulated device study