189
Participants
Start Date
August 13, 2018
Primary Completion Date
February 26, 2024
Study Completion Date
May 13, 2025
Atezolizumab
atezolizumab administered IV 1200 mg Q3W, starting one week before EBRT (Week -1) and continued as an adjuvant for a total maximum of 20 cycles.
Radiotherapy
"* Pelvic +/- para-aortic EBRT (IMRT): 45 Gy in 25 fractions over 5 weeks (Weeks 1-5, with simultaneously integrated boosts to macroscopically involved lymph nodes, if any, in order to deliver a total dose of 60 Gy to macroscopic lymph nodes (including the dose delivered by brachytherapy).~* Uterovaginal brachytherapy (Week 7; maximum interval between EBRT and brachytherapy: 14 days). If appropriate and feasible, dose escalation will be assumed, particularly for advanced disease, with the objective to deliver a total dose of 85 Gy (equivalent dose in 2-Gy fractions with α/β=10 Gy) to 80% of the High Risk-Clinical Target Volume (HR-CTV), including 45 Gy through EBRT. The total dose might be lower in case of close proximity to organs at risk (OARs).~* Total duration of RT (including brachytherapy) should be ≤ 55 days."
Cisplatin
"* Cisplatin infused 40 mg/m2 (maximum 70 mg) weekly IV during EBRT (Weeks 1-5).~* Not administered: during the interval between EBRT and brachytherapy, or during brachytherapy, or if radiotherapy is interrupted."
Gustave Roussy, Villejuif
Gustave Roussy, Cancer Campus, Grand Paris
OTHER