Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endometrial Cancer RAINBO BLUE & TAPER
Endometrial CancerThis 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 - KelownaKelowna, British Columbia
Canada
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Hamid Raziee
Verspeeten Family Cancer Centre
Verspeeten Family Cancer CentreLondon, Ontario
Canada
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Lucas Mendez
519 685-8600CHUM-Centre Hospitalier de l'Universite de Montreal
CHUM-Centre Hospitalier de l'Universite de MontrealMontreal, Quebec
Canada
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Maroie Barkati
514 890-8254Cross Cancer Institute
Cross Cancer InstituteEdmonton, Alberta
Canada
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Fleur Huang
780 432-8516BCCA - Victoria
BCCA - VictoriaVictoria, British Columbia
Canada
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Caroline Holloway
250 519-5609University Health Network
University Health NetworkToronto, Ontario
Canada
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Kathy Han
416 946-4501BCCA - Prince George
BCCA - Prince GeorgePrince George, British Columbia
Canada
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Allison Ye
250 645-7300Trillium Health Partners - Credit Valley Hospital
Trillium Health Partners - Credit Valley HospitalMississauga, Ontario
Canada
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Katherine Pulman
905 813-1100The Jewish General Hospital
The Jewish General HospitalMontreal, Quebec
Canada
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Susie K.S. Lau
514 340-8222Arthur J.E. Child Comprehensive Cancer Centre
Arthur J.E. Child Comprehensive Cancer CentreCalgary, Alberta
Canada
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Tien Phan
403 521-3926BCCA - Vancouver
BCCA - VancouverVancouver, British Columbia
Canada
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Jessica McAlpine
604 877-6000Odette Cancer Centre
Odette Cancer CentreToronto, Ontario
Canada
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Helen MacKay
416 480-5145CIUSSS de l'Estrie - Centre hospitalier
CIUSSS de l'Estrie - Centre hospitalierSherbrooke, Quebec
Canada
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Mathieu Viau
- Study Sponsored By
- Canadian Cancer Trials Group
- Participants Required
- More Information
- Study ID:
NCT05640999