1,615
Participants
Start Date
November 11, 2021
Primary Completion Date
January 1, 2030
Study Completion Date
January 1, 2031
Olaparib
300 mg twice daily for one year
Pelvic external beam radiotherapy
45.0-48.6 Gy; 1.8-2.0 Gy per fraction, 5 fractions a week
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.
Durvalumab
1500 mg intravenous once every 4 weeks for in total 1 year (13 cycles) starting within the first week of radiotherapy,
Medroxyprogesterone Acetate
Oral medroxyprogesterone acetate for two years
Megestrol Acetate
Oral medroxyprogesterone acetate for two years
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).
Observation
No adjuvant therapy
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
RECRUITING
The MMRd-GREEN trial: Leiden University Medical Center, Leiden
Collaborators (1)
Institute Gustave Roussy (sponsor p53abn-RED trial)
UNKNOWN
Leiden University Medical center (sponsor MMRd-GREEN trial)
UNKNOWN
University College London (sponsor NSMP-ORANGE trial)
UNKNOWN
Canadian Clinical Trials Group (sponsor POLEmut-BLUE trial)
UNKNOWN
Dutch Gynaecological Oncology Group
OTHER
Comprehensive Cancer Centre The Netherlands
OTHER
Cancer Research UK & UCL Cancer Trials Centre
OTHER
Dutch Cancer Society
OTHER
AstraZeneca
INDUSTRY
National Cancer Institute, France
OTHER_GOV
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Leiden University Medical Center
OTHER