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Studies

Interventional Recruiting Phase 2

NCT05640999 on ClinicalTrials.gov

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

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

  • Sponsor: Canadian Cancer Trials Group
  • Collaborators: Canadian 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, University College, London
  • Enrollment: 393 (Estimated)
  • Study start: 2022-12-19 (Actual)
  • Primary completion: 2028-12-31 (Estimated)
  • Study completion: 2029-06-30 (Estimated)
  • Allocation: Non-Randomized
  • InterventionModel: Parallel
  • Masking: None
  • PrimaryPurpose: Treatment

Brief 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

  • Endometrial Cancer

Intervention / Treatment

  • Radiation: Vaginal brachytherapy
  • Radiation: Adjuvant radiotherapy (EBRT +/- brachytherapy)
  • Other: Observation

Primary Outcome Measures

  • 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)

Countries

Australia, Canada, France, Germany, Italy, Netherlands, New Zealand, Norway, United States

Locations and Investigators

  • Alaska Womens Cancer Care, Anchorage, United States (Recruiting)
    • Melissa Hardesty
  • University of Arizona Cancer Center, Tucson, United States (Recruiting)
    • Marina Miller
  • Cedars-Sinai Medical Center, Los Angeles, United States (Recruiting)
    • Emily Prendergast
  • Huntington Memorial Hospital, Pasadena, United States (Recruiting)
    • Emily Prendergast
  • Sutter Medical Center Sacramento, Sacramento, United States (Recruiting)
    • Anna Likhacheva
  • UCHealth University of Colorado Hospital, Aurora, United States (Recruiting)
    • Bradley Corr
  • AdventHealth Porter, Denver, United States (Recruiting)
    • Neil Phippen
  • UM Sylvester Comprehensive Cancer Center at, Deerfield Beach, United States (Recruiting)
    • Joseph Pearson
  • UM Sylvester Comprehensive Cancer Center at Doral, Doral, United States (Recruiting)
    • Joseph Pearson
  • University of Florida, Gainesville, United States (Recruiting)
    • Danielle Cerbon
  • University of Miami School of Medicine, Miami, United States (Recruiting)
    • Joseph Pearson
  • Sarasota Memorial Hospital - Venice, N. Venice, United States (Recruiting)
    • Beverly Long
  • University of Miami Sylvester, North Miami, United States (Recruiting)
    • Joseph Pearson
  • UM Sylvester Comprehensive Cancer Center, Plantation, United States (Recruiting)
    • Joseph Pearson
  • Florida Cancer Specialists - Sarasota Downtown, Sarasota, United States (Recruiting)
    • Beverly Long
  • First Physicians Group-Sarasota, Sarasota, United States (Recruiting)
    • Beverly Long
  • Sarasota Memorial Hospital, Sarasota, United States (Recruiting)
    • Beverly Long
  • Sarasota Memorial Health Care Centre, Sarasota, United States (Recruiting)
    • Beverly Long
  • Florida Cancer Specialists - Venice Pinebrook, Venice, United States (Recruiting)
    • Beverly Long
  • Grady Health System, Atlanta, United States (Recruiting)
    • Jill Remick
  • Emory University Hospital Midtown, Atlanta, United States (Recruiting)
    • Jill Remick
  • Piedmont Hospital, Atlanta, United States (Recruiting)
    • Leda Gattoc
  • Emory University Hospital Winship Cancer Institute, Atlanta, United States (Recruiting)
    • Jill Remick
  • Emory Saint Josephs Hospital, Atlanta, United States (Recruiting)
    • Jill Remick
  • Emory Decatur Hospital, Decatur, United States (Recruiting)
    • Jill Remick
  • Northwestern University, Chicago, United States (Recruiting)
    • Dario Roque
  • Northwestern Medicine Orland Park, Orland Park, United States (Recruiting)
    • Dario Roque
  • Northwestern Medicine Cancer Center Warrenville, Warrenville, United States (Recruiting)
    • Dario Roque
  • Ascension Saint Vincent Indianapolis Hospital, Indianapolis, United States (Recruiting)
    • Megan Buechel
  • Norton Hospital Pavilion and Medical Campus, Louisville, United States (Recruiting)
    • Monica Vetter
  • Norton Suburban Hospital and Medical Campus, Louisville, United States (Recruiting)
    • Monica Vetter
  • University Medical Center New Orleans, New Orleans, United States (Recruiting)
    • Tara Castellano
  • Massachusetts General Hospital Cancer Center, Boston, United States (Recruiting)
    • Andrea Russo
  • Baystate Medical Center, Springfield, United States (Recruiting)
    • Tashanna Myers
  • UMass Memorial Medical Centre, Worcester, United States (Recruiting)
    • Susan Zweizig
  • Mercy Hospital, Coon Rapids, United States (Recruiting)
    • Annie Tan
  • Washington University School of Medicine, St Louis, United States (Recruiting)
    • Premal Thaker
  • Nebraska Methodist Hospital, Omaha, United States (Recruiting)
    • Brent Tierney
  • Womens Cancer Center of Nevada, Las Vegas, United States (Recruiting)
    • Nicola Spirtos
  • Sidney Kimmel Cancer Center Washington Township, Sewell, United States (Recruiting)
    • Mitchell Edelson
  • Roswell Park Cancer Institute, Buffalo, United States (Recruiting)
    • Emese Zsiros
  • Mount Sinai Chelsea, New York, United States (Recruiting)
    • Caitlin Carr
  • Mount Sinai Hospital, New York, United States (Recruiting)
    • Caitlin Carr
  • Upstate Cancer Center Radiation Oncology at Oswego, Oswego, United States (Recruiting)
    • Mary Cunningham
  • State University of New York, Syracuse, United States (Recruiting)
    • Mary Cunningham
  • Upstate Cancer Center at Hill Radiation Oncology, Syracuse, United States (Recruiting)
    • Mary Cunningham
  • Upstate Cancer Center at Verona, Verona, United States (Recruiting)
    • Mary Cunningham
  • UNC Lineberger Comprehensive Cancer Center, Chapel Hill, United States (Recruiting)
    • Olivia Lara
  • Duke University Medical Center, Durham, United States (Recruiting)
    • Angeles Secord
  • Duke Womens Cancer Care Raleigh, Raleigh, United States (Recruiting)
    • Angeles Secord

And 73 other sites.

Study Officials