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Brief Title: ENGOT-cx1/BGOG-cx1: 3 Weekly Carboplatin/Paclitaxel With or Without Nintedanib in Cervix Cancer
Official Title: BGOG-cx1/ENGOT-cx1: "Randomized Double-blind Phase II Study Comparing 3-weekly Carboplatin + Paclitaxel With or Without Concomitant and Maintenance Nintedanib (NINTEDANIB) in Advanced or Recurrent Cervical Carcinoma."
Study ID: NCT02009579
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
CHU Saint-Pierre, Bruxelles, , Belgium
Institut Jules Bordet, Bruxelles, , Belgium
Grand Hopital de Charleroi, Charleroi, , Belgium
UZ Antwerpen, Edegem, , Belgium
AZ Groeninge, Kortrijk, , Belgium
UZ Leuven, Leuven, , Belgium
CHR Citadelle, Liege, , Belgium
CHU de Liège, Liège, , Belgium
Clinique et maternite St. Elisabeth, Namur, , Belgium
Cliniques Universitaires mont godinne, Yvoir, , Belgium
Charité Med Uni Berlin, Berlin, , Germany
Universitätsklinikum Carl Gustav Carus Dresden, Dresden, , Germany
Kliniken Essen Mitte, Essen, , Germany
Georg-August University Göttingen, Gottingen, , Germany
Medical University Greifswald, Greifswald, , Germany
University Tübingen, Tubingen, , Germany
Centro Riferimento Oncologico, Aviano, , Italy
Spedali Civili, Brescia, , Italy
Azienda Ospedaliera Cannizzaro, Catania, , Italy
National Cancer Institute, Milano, , Italy
Istituto Nazionale Tumori-Pascale Naples, Naples, , Italy
Padova Istituti Oncologico Veneto, Padova, , Italy
University Pisa, Pisa, , Italy
AUSL Reggio Emilia, Reggio Emilia, , Italy
Poloclinico A Gemelli, Rome, , Italy
Mauriziano -Torino, Torino, , Italy
S. Anna Torino, Torino, , Italy
Hospital Provincial Reina Sofia, Córdoba, , Spain
H. Ramón y Cajal, Madrid, , Spain
Hospital Clinico San Carlos, Madrid, , Spain
Hospital Universitario Morales Meseguer, Murcia, , Spain
Hospital Son Llatzer, Palma Mallorca, , Spain