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

Endometrial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05640999
• Other study ID #: EN10
• Secondary ID: NRG-GY032
• Status: Recruiting
• Phase: Phase 2
• Start date: December 19, 2022
• Est. completion date: June 30, 2029

Study information

• Verified date: November 2023
• Source: Canadian Cancer Trials Group
• Contact: Wendy Parulekar
• Phone: 613-533-6430
• Email: wparulekar[@]ctg.queensu.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

This study is being done in order to find out if this new approach is better or worse than the usual approach for early-stage endometrial cancer. The usual approach is defined as the care most people get for early-stage endometrial cancer.

The usual approach for patients who are not in a study is treatment with surgery. Tissue that is removed as part of this procedure is analyzed in the pathology laboratory to guide the doctor to decide whether or not additional treatment such as radiation and or chemotherapy should be recommended.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 325
• Est. completion date: June 30, 2029
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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) (

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

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

Locations

Country	Name	City	State
Australia	Monash Medical Centre	Clayton	Victoria
Australia	The Royal Women's Hospital	Parkville	Victoria
Australia	Westmead Hospital	Westmead	New South Wales
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	BCCA - Kelowna	Kelowna	British Columbia
Canada	London Regional Cancer Program	London	Ontario
Canada	Trillium Health Partners - Credit Valley Hospital	Mississauga	Ontario
Canada	CHUM-Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec
Canada	BCCA - Prince George	Prince George	British Columbia
Canada	CIUSSS de l'Estrie - Centre hospitalier	Sherbrooke	Quebec
Canada	Odette Cancer Centre	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario
Canada	BCCA - Vancouver	Vancouver	British Columbia
Canada	BCCA - Victoria	Victoria	British Columbia
Netherlands	Catharina ziekenhuis	Eindhoven	Noord Brabant
Netherlands	Leiden University Medical Center (LUMC)	Leiden
Netherlands	Maastro clinic (Maastricht UMC)	Maastricht	Limburg
Netherlands	Erasmus Medical Center (EMC)	Rotterdam

Sponsors (2)

Lead Sponsor	Collaborator
Canadian Cancer Trials Group	Canadian Cancer Clinical Trials Network

Countries where clinical trial is conducted

Australia,  Canada,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Estimate the rate of isolated vaginal recurrence at 3 years		3 years
Secondary	Estimate the rate of para-aortic recurrence at 3 years		3 years
Secondary	Estimate the rate of distant metastasis at 3 years		3 years
Secondary	Estimate recurrence-free survival		9 years
Secondary	Estimate endometrial cancer-specific survival		9 years
Secondary	Estimate overall survival		9 years
Secondary	Describe the impact of molecular classification on fear of recurrence by Fear of Recurrence Inventory		9 years