Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 2

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

NCT05640999 · View on ClinicalTrials.gov ↗

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

Conditions Studied

Interventions

  • OTHER Observation
  • RADIATION Vaginal brachytherapy
  • RADIATION Adjuvant radiotherapy (EBRT +/- brachytherapy)

Study Locations (20)

Florida

  • University of Miami School of Medicine — Miami
  • Sarasota Memorial Hospital - Venice — N. Venice
  • Florida Cancer Specialists - Sarasota Downtown — Sarasota
  • First Physicians Group-Sarasota — Sarasota
  • Sarasota Memorial Hospital — Sarasota
  • Sarasota Memorial Health Care Centre — Sarasota
  • Florida Cancer Specialists - Venice Pinebrook — Venice

Georgia

  • Grady Health System — Atlanta
  • Emory University Hospital Midtown — Atlanta
  • Piedmont Hospital — Atlanta
  • Emory University Hospital Winship Cancer Institute — Atlanta
  • Emory Saint Josephs Hospital — Atlanta
  • Emory Decatur Hospital — Decatur

California

  • Cedars-Sinai Medical Center — Los Angeles
  • Huntington Memorial Hospital — Pasadena
  • Sutter Medical Center Sacramento — Sacramento

Colorado

  • UCHealth University of Colorado Hospital — Aurora
  • AdventHealth Porter — Denver

Alaska

  • Alaska Womens Cancer Care — Anchorage

Arizona

  • University of Arizona Cancer Center — Tucson

Trial Details

FieldValue
Enrollment Target 393 participants
Start Date 2022-12-19
Est. Completion 2029-06-30
Phase Phase 2

Sponsor

Canadian Cancer Trials Group

102 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05640999

The ClinicalTrials.gov registry entry for NCT05640999 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 393 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Canadian Cancer Trials Group, which has 102 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Endometrial Cancer appearing as the primary indexed condition, and to 3 interventions — of which Observation is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05640999 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Florida, Georgia, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05640999 about?

NCT05640999 is a clinical study titled "Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endometrial Cancer RAINBO BLUE & TAPER". 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 / N...

What is the current status of trial NCT05640999?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 393 participants. The study started on 2022-12-19. Estimated completion is 2029-06-30.

What conditions does trial NCT05640999 study?

This clinical trial studies the following conditions: Endometrial Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05640999?

The interventions under investigation include: Observation (OTHER), Vaginal brachytherapy (RADIATION), Adjuvant radiotherapy (EBRT +/- brachytherapy) (RADIATION). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05640999?

This trial is sponsored by Canadian Cancer Trials Group, which has 102 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05640999 being conducted?

This trial has 20 study locations across Alaska, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial