Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endometrial Cancer RAINBO BLUE & TAPER
Condition(s) studied
Investigational drug(s) / intervention(s)
Vaginal brachytherapy: Vaginal brachytherapy should be delivered using a vaginal cylinder, or alternatively ovoids
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.
Observation: Observation
Study 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
Primary outcome measure(s)
- Estimate the rate of pelvic recurrence at 3 years in patients who are treated with de-escalated adjuvant treatment directed by tumour molecular status — 3 years
Trial sites (122)
| Facility | City | Region | Status |
|---|---|---|---|
| Alaska Womens Cancer Care | Anchorage | Alaska | Recruiting |
| University of Arizona Cancer Center | Tucson | Arizona | Recruiting |
| Cedars-Sinai Medical Center | Los Angeles | California | Recruiting |
| Huntington Memorial Hospital | Pasadena | California | Recruiting |
| Sutter Medical Center Sacramento | Sacramento | California | Recruiting |
| UCHealth University of Colorado Hospital | Aurora | Colorado | Recruiting |
| AdventHealth Porter | Denver | Colorado | Recruiting |
| UM Sylvester Comprehensive Cancer Center at | Deerfield Beach | Florida | Recruiting |
| UM Sylvester Comprehensive Cancer Center at Doral | Doral | Florida | Recruiting |
| University of Florida | Gainesville | Florida | Recruiting |
| University of Miami School of Medicine | Miami | Florida | Recruiting |
| Sarasota Memorial Hospital - Venice | N. Venice | Florida | Recruiting |
| University of Miami Sylvester | North Miami | Florida | Recruiting |
| UM Sylvester Comprehensive Cancer Center | Plantation | Florida | Recruiting |
| Florida Cancer Specialists - Sarasota Downtown | Sarasota | Florida | Recruiting |
| First Physicians Group-Sarasota | Sarasota | Florida | Recruiting |
| Sarasota Memorial Hospital | Sarasota | Florida | Recruiting |
| Sarasota Memorial Health Care Centre | Sarasota | Florida | Recruiting |
| Florida Cancer Specialists - Venice Pinebrook | Venice | Florida | Recruiting |
| Grady Health System | Atlanta | Georgia | Recruiting |
| Emory University Hospital Midtown | Atlanta | Georgia | Recruiting |
| Piedmont Hospital | Atlanta | Georgia | Recruiting |
| Emory University Hospital Winship Cancer Institute | Atlanta | Georgia | Recruiting |
| Emory Saint Josephs Hospital | Atlanta | Georgia | Recruiting |
| Emory Decatur Hospital | Decatur | Georgia | Recruiting |
| Northwestern University | Chicago | Illinois | Recruiting |
| Northwestern Medicine Orland Park | Orland Park | Illinois | Recruiting |
| Northwestern Medicine Cancer Center Warrenville | Warrenville | Illinois | Recruiting |
| Ascension Saint Vincent Indianapolis Hospital | Indianapolis | Indiana | Recruiting |
| Norton Hospital Pavilion and Medical Campus | Louisville | Kentucky | Recruiting |
| Norton Suburban Hospital and Medical Campus | Louisville | Kentucky | Recruiting |
| University Medical Center New Orleans | New Orleans | Louisiana | Recruiting |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | Recruiting |
| Baystate Medical Center | Springfield | Massachusetts | Recruiting |
| UMass Memorial Medical Centre | Worcester | Massachusetts | Recruiting |
| Mercy Hospital | Coon Rapids | Minnesota | Recruiting |
| Washington University School of Medicine | St Louis | Missouri | Recruiting |
| Nebraska Methodist Hospital | Omaha | Nebraska | Recruiting |
| Womens Cancer Center of Nevada | Las Vegas | Nevada | Recruiting |
| Sidney Kimmel Cancer Center Washington Township | Sewell | New Jersey | Recruiting |
+ 82 more sites — see the full list on the official registry below.
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05640999 on ClinicalTrials.gov ↗ ← All trials in Italy