At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed endometrial cancer of specified histotypes (endometrioid, serous, clear cell, dedifferentiated, undifferentiated, carcinosarcoma, or mixed)
- ✓Full molecular classification per WHO 2020 diagnostic algorithm
- ✓Hysterectomy and bilateral salpingo-oophorectomy with or without lymphadenectomy/sentinel node biopsy, no macroscopic residual disease
- ✓No distant metastases on imaging
- ✕History of another primary malignancy in past 5 years, except non-melanoma skin cancer
- ✕Prior pelvic radiation
- ✕Pathogenic POLE mutation(s) for p53abn-RED, MMRd-GREEN, and NSMP-ORANGE trials
- ✕Mismatch repair deficiency for p53abn-RED and NSMP-ORANGE trials
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features: the p53abn-RED Trial, the MMRd-GREEN Trial, the NSMP-ORANGE Trial and the POLEmut-BLUE Trial
In Brief
A Phase 3 clinical trial evaluating Olaparib, Pelvic external beam radiotherapy, and 6 other interventions for Endometrial Cancer. Currently recruiting, targeting 1,615 participants across 14 sites in 4 countries.
Signals
Detailed Summary
The RAINBO umbrella program consists of four clinical trials investigating new adjuvant therapies in endometrial cancer patients. Eligible patients will be assigned to one of the four RAINBO trials based on the molecular profile of their cancer: * p53 abnormal endometrial cancer patients to the p53abn-RED trial * mismatch repair deficient endometrial cancer patients to the MMRd-GREEN trial * no specific molecular profile endometrial cancer patients to NSMP-ORANGE trial * POLE mutant endometrial cancer patients to the POLEmut-BLUE trial
Study Details
Timeline
Interventions
300 mg twice daily for one year
45.0-48.6 Gy; 1.8-2.0 Gy per fraction, 5 fractions a week
Preferably concurrent and adjuvant according to the PORTEC-3 schedule: two cycles of intravenous cisplatin 50mg/m² in the first and fourth week of the pelvic external beam radiotherapy followed by four cycles of intravenous carboplatin AUC 5 and paclitaxel 175 mg/m² at 21-day intervals.
1500 mg intravenous once every 4 weeks for in total 1 year (13 cycles) starting within the first week of radiotherapy,
Oral medroxyprogesterone acetate for two years
Oral medroxyprogesterone acetate for two years
Vaginal brachytherapy is to be considered in patients with documented cervical stromal involvement and/or substantial LVSI. Brachytherapy is given with a vaginal cylinder or vaginal ovoids or ring applicator, according to the center's standard technique. When using a cylinder, the active length will ideally be 2-3 cm, with the reference isodose covering the proximal 2.5-3 cm of the vagina. High-dose-rate (HDR) and pulse-dose-rate (PDR) schedules are permitted, which deliver an EQD2 equivalent dose of 10-14 Gy at 5 mm from the vaginal mucosa (to obtain a cumulative EDQ2 of 60 Gy at 5 mm).
No adjuvant therapy