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

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

Interventions

RADIATION

Vaginal brachytherapy

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

RADIATION

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.

OTHER

Observation

Observation

Sponsors & Collaborators

• Canadian Cancer Clinical Trials Network

  collaborator UNKNOWN

• Australia New Zealand Gynaecological Oncology Group

  collaborator OTHER

• Gustave Roussy, Cancer Campus, Grand Paris

  collaborator OTHER

• Leiden University Medical Center

  collaborator OTHER

• Mario Negri Gynecologic Oncology group (MaNGO)

  collaborator OTHER

• NRG Oncology

  collaborator OTHER

• Philipps University Marburg

  collaborator OTHER

• Canadian Cancer Trials Group

  lead NETWORK

Principal Investigators

• Kathy Han · University Health Network, Princess Margaret Hospital, Toronto ON Canada

• Jessica McAlpine · BCCA-Vancouver Cancer Centre, Vancouver BC Canada

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-12-19

Primary Completion

2028-12-31

Completion

2029-06-30

FDA Device

Yes

Countries

• United States
• Australia
• Canada
• France
• Italy
• Netherlands
• New Zealand
• Norway

Study Locations