CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 393 target
Drug / intervention
Vaginal brachytherapy +2 moreradiation
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Hysterectomy and bilateral salpingo-oophorectomy with no macroscopic residual disease
  • ✓Histologically confirmed Stage I to III endometrial carcinoma (endometrioid, serous, clear cell, un/dedifferentiated, carcinosarcoma or mixed)
  • ✓Age ≥18 years
  • ✓Accessible for treatment and follow-up at participating centre
Key exclusion· 6
  • ✕Prior neoadjuvant chemotherapy for current endometrial cancer diagnosis
  • ✕Prior pelvic radiation
  • ✕History of other malignancies except: carcinoma in-situ without invasive disease, adequately treated non-melanoma skin cancer, or other tumours curatively treated with no disease for ≥5 years
  • ✕Clinical evidence of distant metastasis on imaging (CT or PET-CT)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05640999
NCT05640999Phase 2RecruitingHigh Momentum
Long Recruiting
CompareCT.gov

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

Canadian Cancer Trials Group·interventional·Posted Dec 7, 2022·Updated Jun 9, 2026

In Brief

A Phase 2 clinical trial evaluating Vaginal brachytherapy, Adjuvant radiotherapy (EBRT +/- brachytherapy), and 1 other intervention for Endometrial Cancer. Currently recruiting, targeting 393 participants across 110 sites in 8 countries.

Signals

Enrolling ahead of pace

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEndometrial Cancer
CountriesAustralia, Canada, France, Italy, Netherlands, New Zealand, Norway, United States
CollaboratorsCanadian Cancer Clinical Trials Network, Australia New Zealand Gynaecological Oncology Group, Gustave Roussy, Cancer Campus, Grand Paris, Leiden University Medical Center, Mario Negri Gynecologic Oncology group (MaNGO), NRG Oncology, Philipps University Marburg

Timeline

Phase 2Recruiting
2023202420252026202720282029
First PostedDec 7, 2022
Enrollment StartDec 19, 2022
Primary CompletionDec 31, 2028
Study CompletionJun 30, 2029
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 3.6 years agoPrimary completion in 2.5 years

Arms & Interventions

Sub-study A: RAINBO BLUE Cohort A1experimental

Observation

Other: Observation
Sub-Study A: RAINBO BLUE Cohort A2experimental

Observation or Adjuvant Radiotherapy

Radiation: Adjuvant radiotherapy (EBRT +/- brachytherapy)Other: Observation
Sub-Study B: TAPERexperimental

Observation or Vaginal Brachytherapy

Radiation: Vaginal brachytherapyOther: Observation

Interventions

Vaginal brachytherapyradiation

Vaginal brachytherapy should be delivered using a vaginal cylinder, or alternatively ovoids

Adjuvant radiotherapy (EBRT +/- brachytherapy)radiation

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.

Observationother

Observation