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Spots Global Cancer Trial Database for ENGOT-cx1/BGOG-cx1: 3 Weekly Carboplatin/Paclitaxel With or Without Nintedanib in Cervix Cancer

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Trial Identification

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

Interventions

Nintedanib
Placebo

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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