ENGOT-cx1/BGOG-cx1: 3 Weekly Carboplatin/Paclitaxel With or Without Nintedanib in Cervix Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

March 31, 2014

Primary Completion Date

January 31, 2021

Study Completion Date

October 31, 2023

Conditions
Uterine Cervical Neoplasms
Interventions
DRUG

Nintedanib

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.

DRUG

Placebo

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.

Trial Locations (32)

3000

UZ Leuven, Leuven

4000

CHU de Liège, Liège

14004

Hospital Provincial Reina Sofia, Córdoba

28034

H. Ramón y Cajal, Madrid

28040

Hospital Clinico San Carlos, Madrid

30008

Hospital Universitario Morales Meseguer, Murcia

Unknown

CHU Saint-Pierre, Brussels

Institut Jules Bordet, Brussels

Grand Hopital de Charleroi, Charleroi

UZ Antwerpen, Edegem

AZ Groeninge, Kortrijk

CHR Citadelle, Liège

Clinique et maternite St. Elisabeth, Namur

Cliniques Universitaires mont godinne, Yvoir

Charité Med Uni Berlin, Berlin

Universitätsklinikum Carl Gustav Carus Dresden, Dresden

Kliniken Essen Mitte, Essen

Georg-August University Göttingen, Göttingen

Medical University Greifswald, Greifswald

University Tübingen, Tübingen

Centro Riferimento Oncologico, Aviano

Spedali Civili, Brescia

Azienda Ospedaliera Cannizzaro, Catania

National Cancer Institute, Milan

Istituto Nazionale Tumori-Pascale Naples, Naples

Padova Istituti Oncologico Veneto, Padua

University Pisa, Pisa

AUSL Reggio Emilia, Reggio Emilia

Poloclinico A Gemelli, Rome

Mauriziano -Torino, Torino

S. Anna Torino, Torino

07198

Hospital Son Llatzer, Palma Mallorca

All Listed Sponsors
collaborator

Grupo Español de Investigación en Cáncer de Ovario

OTHER

collaborator

Mario Negri Gynecologic Oncology group (MaNGO)

OTHER

collaborator

Multicenter Italian Trials in Ovarian Cancer (MITO)

UNKNOWN

collaborator

North Eastern German Society of Gynaecological Oncology

OTHER

lead

Belgian Gynaecological Oncology Group

OTHER

NCT02009579 - ENGOT-cx1/BGOG-cx1: 3 Weekly Carboplatin/Paclitaxel With or Without Nintedanib in Cervix Cancer | Biotech Hunter | Biotech Hunter