ENGOT-cx1/BGOG-cx1: 3 Weekly Carboplatin/Paclitaxel With or Without Nintedanib in Cervix Cancer
Status:
Active, not recruiting
Trial end date:
2023-07-01
Target enrollment:
Participant gender:
Summary
Indication:
Treatment of subjects with advanced (FIGO stage IVB) or recurrent cervical cancer, prior
radiochemotherapy or neo-adjuvant chemotherapy is allowed.
Study design:
This is a phase II randomized, double blind and placebo controlled trial evaluating the
efficacy of Nintedanib/placebo in combination with the standard carboplatin and paclitaxel
followed by Nintedanib/placebo maintenance in the treatment of patients with advanced or
recurrent cervical cancer.
A total of 120 patients will be randomized between the experimental and control arm in a 1:1
ratio. Randomization will be stratified for 1previous chemotherapy for metastatic disease
(yes/no) and 2disease status (Stage IVB primary versus recurrent disease).
Experimental arm: Subjects will receive 6 cycles of 3-weekly carboplatin (AUC 5) + paclitaxel
(175 mg/m2) and Nintedanib 200 mg BID followed by Nintedanib maintenance until progression or
for a total maximum duration of 120 weeks.
Control arm: Subjects will receive 6 cycles of 3-weekly carboplatin (AUC 5) + paclitaxel (175
mg/m2) and placebo 200 mg BID followed by placebo maintenance until progression or for a
total maximum duration of 120 weeks.
Subjects without evidence of disease progression after completion or discontinuation of the
study treatment will be followed until radiographic disease progression, withdrawal of
consent or death.
Phase:
Phase 2
Details
Lead Sponsor:
Belgian Gynaecological Oncology Group
Collaborators:
Grupo Español de Investigación en Cáncer de Ovario Institute of Cancer Research, United Kingdom Mario Negri Gynecologic Oncology group (MaNGO) Multicenter Italian Trials in Ovarian Cancer (MITO) Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie (NOGGO) North Eastern German Society of Gynaecological Oncology