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

Endometrial Cancer

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

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Participation Requirements

  • Sex:

    FEMALE
  • Eligible Ages:

    18 and up

Participation Criteria

Inclusion Criteria:

* Patients must have had surgery consisting of hysterectomy and bilateral salpingo-oophorectomy. Lymph node dissection can be performed as per institutional standards. There must be no macroscopic residual disease after surgery.
* Patients must have histologically confirmed Stage I to III endometrial carcinoma which can be endometrioid, serous, clear cell, un/dedifferentiated, carcinosarcoma or mixed.
* Patients' Eastern Cooperative Group (ECOG) performance status must be 0, 1, or 2.
* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
* Patients' age must be ≥ 18 years.
* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements.
* Patient is able (i.e. sufficiently fluent) and willing to complete the patient-reported outcomes (PRO) questionnaires in either English, French or a validated language
* Patients must be accessible for treatment and follow-up. Patients enrolled on this trial must be treated and followed at the participating centre
* Protocol treatment is to begin within 10 weeks of hysterectomy/bilateral salpingo-oophorectomy

Exclusion Criteria:

* Prior Neoadjuvant chemotherapy for current endometrial cancer diagnosis.
* Prior pelvic radiation.
* Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years.
* Clinical evidence of distant metastasis as determined by pre-surgical or post-surgical imaging (CT scan of chest, abdomen and pelvis or whole-body PET-CT scan) (

Study Location

BCCA - Kelowna
BCCA - Kelowna
Kelowna, British Columbia
Canada

Contact Study Team

Primary Contact

Hamid Raziee

Verspeeten Family Cancer Centre
Verspeeten Family Cancer Centre
London, Ontario
Canada

Contact Study Team

Primary Contact

Lucas Mendez

519 685-8600
CHUM-Centre Hospitalier de l'Universite de Montreal
CHUM-Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec
Canada

Contact Study Team

Primary Contact

Maroie Barkati

514 890-8254
Cross Cancer Institute
Cross Cancer Institute
Edmonton, Alberta
Canada

Contact Study Team

Primary Contact

Fleur Huang

780 432-8516
BCCA - Victoria
BCCA - Victoria
Victoria, British Columbia
Canada

Contact Study Team

Primary Contact

Caroline Holloway

250 519-5609
University Health Network
University Health Network
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Kathy Han

416 946-4501
BCCA - Prince George
BCCA - Prince George
Prince George, British Columbia
Canada

Contact Study Team

Primary Contact

Allison Ye

250 645-7300
Trillium Health Partners - Credit Valley Hospital
Trillium Health Partners - Credit Valley Hospital
Mississauga, Ontario
Canada

Contact Study Team

Primary Contact

Katherine Pulman

905 813-1100
The Jewish General Hospital
The Jewish General Hospital
Montreal, Quebec
Canada

Contact Study Team

Primary Contact

Susie K.S. Lau

514 340-8222
Arthur J.E. Child Comprehensive Cancer Centre
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta
Canada

Contact Study Team

Primary Contact

Tien Phan

403 521-3926
BCCA - Vancouver
BCCA - Vancouver
Vancouver, British Columbia
Canada

Contact Study Team

Primary Contact

Jessica McAlpine

604 877-6000
Odette Cancer Centre
Odette Cancer Centre
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Helen MacKay

416 480-5145
CIUSSS de l'Estrie - Centre hospitalier
CIUSSS de l'Estrie - Centre hospitalier
Sherbrooke, Quebec
Canada

Contact Study Team

Primary Contact

Mathieu Viau

Study Sponsored By
Canadian Cancer Trials Group
Participants Required
More Information
Study ID: NCT05640999