Refining Adjuvant Treatment in Endometrial Cancer Based on Molecular Features

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

1,615

Participants

Timeline

Start Date

November 11, 2021

Primary Completion Date

January 1, 2030

Study Completion Date

January 1, 2031

Conditions
Endometrial Cancer
Interventions
DRUG

Olaparib

300 mg twice daily for one year

RADIATION

Pelvic external beam radiotherapy

45.0-48.6 Gy; 1.8-2.0 Gy per fraction, 5 fractions a week

DRUG

Chemotherapy

Preferably concurrent and adjuvant according to the PORTEC-3 schedule: two cycles of intravenous cisplatin 50mg/m² in the first and fourth week of the pelvic external beam radiotherapy followed by four cycles of intravenous carboplatin AUC 5 and paclitaxel 175 mg/m² at 21-day intervals.

DRUG

Durvalumab

1500 mg intravenous once every 4 weeks for in total 1 year (13 cycles) starting within the first week of radiotherapy,

DRUG

Medroxyprogesterone Acetate

Oral medroxyprogesterone acetate for two years

DRUG

Megestrol Acetate

Oral medroxyprogesterone acetate for two years

RADIATION

Vaginal brachytherapy

Vaginal brachytherapy is to be considered in patients with documented cervical stromal involvement and/or substantial LVSI. Brachytherapy is given with a vaginal cylinder or vaginal ovoids or ring applicator, according to the center's standard technique. When using a cylinder, the active length will ideally be 2-3 cm, with the reference isodose covering the proximal 2.5-3 cm of the vagina. High-dose-rate (HDR) and pulse-dose-rate (PDR) schedules are permitted, which deliver an EQD2 equivalent dose of 10-14 Gy at 5 mm from the vaginal mucosa (to obtain a cumulative EDQ2 of 60 Gy at 5 mm).

OTHER

Observation

No adjuvant therapy

Trial Locations (14)

Unknown

RECRUITING

The POLEmut-BLUE trial: Princess Margaret Cancer Centre, University of Toronto, Toronto

RECRUITING

The POLEmut-BLUE trial: University of British Columbia, Vancouver

NOT_YET_RECRUITING

The p53abn-RED trial: Institute Gustave Roussy, Villejuif

RECRUITING

Amsterdam University Medical Center, Amsterdam

RECRUITING

Amphia Ziekenhuis, Breda

RECRUITING

Instituut Verbeeten, Breda

RECRUITING

Catharina Ziekenhuis, Eindhoven

RECRUITING

Medisch Spectrum Twente, Enschede

RECRUITING

Universitair Medisch Centrum Groningen, Groningen

RECRUITING

Erasmus Medical Center, Rotterdam

RECRUITING

Haags Medisch Centrum, The Hague

NOT_YET_RECRUITING

The NSMP-ORANGE trial: Barts Health NHS Trust, London

NOT_YET_RECRUITING

The NSMP-ORANGE trial: Manchester Academic Health Science Centre, St Mary's Hospita, Manchester

2333ZA

RECRUITING

The MMRd-GREEN trial: Leiden University Medical Center, Leiden

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Institute Gustave Roussy (sponsor p53abn-RED trial)

UNKNOWN

collaborator

Leiden University Medical center (sponsor MMRd-GREEN trial)

UNKNOWN

collaborator

University College London (sponsor NSMP-ORANGE trial)

UNKNOWN

collaborator

Canadian Clinical Trials Group (sponsor POLEmut-BLUE trial)

UNKNOWN

collaborator

Dutch Gynaecological Oncology Group

OTHER

collaborator

Comprehensive Cancer Centre The Netherlands

OTHER

collaborator

Cancer Research UK & UCL Cancer Trials Centre

OTHER

collaborator

Dutch Cancer Society

OTHER

collaborator

AstraZeneca

INDUSTRY

collaborator

National Cancer Institute, France

OTHER_GOV

collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

lead

Leiden University Medical Center

OTHER