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ACTIVE NOT RECRUITING
NCT03760822
PHASE2

Second-Line Chemotherapy With Ramucirumab +/- Paclitaxel in Elderly Advanced Gastric or Gastroesophageal Junction Cancer Patients

Sponsor: Federation Francophone de Cancerologie Digestive

View on ClinicalTrials.gov

Summary

The primary objective is to evaluate six months survival rate and quality of life at 4 months of ramucirumab alone or in combination with paclitaxel in patients aged 70 years or more who have stomach or GEJ adenocarcinoma and whose first line of fluoropyrimidine- and platinumcontaining treatment has failed. The co-primary endpoints are the following: * Six months survival rate * Quality of life at 4 months as assessed by the following three target dimensions of the EORTC QLQ-ELD14 questionnaire: mobility, illness burden and worries about the future

Key Details

Gender

All

Age Range

70 Years - Any

Study Type

INTERVENTIONAL

Enrollment

112

Start Date

2018-11-16

Completion Date

2024-12

Last Updated

2024-07-08

Healthy Volunteers

No

Interventions

DRUG

Ramucirumab

IV ramucirumab at 8 mg/kg on D1 and D15

DRUG

Paclitaxel

IV paclitaxel at 80 mg/m² on D1, D8 and D15

Locations (38)

CH -

Abbeville, France

CH - Albi

Albi, France

PRIVEE - L'Europe

Amiens, France

CAC - ICO Site Paul Papin

Angers, France

Privee - Hopital Prive

Antony, France

Ch - Victor Dupouy

Argenteuil, France

Ch - Metz Thionville Mercy

Ars-Laquenexy, France

Ch - Ght Unyon Auxerre

Auxerre, France

Privee - Institut Du Cancer Avignon Provence

Avignon, France

Ch - Cote Basque

Bayonne, France

Ch - Beauvais Ch

Beauvais, France

Chu - Jean Minjoz

Besançon, France

Privee - Tivoli

Bordeaux, France

PRIVEE - Polyclinique Saint Privat

Boujan-sur-Libron, France

Ch - Duchenne

Boulogne-sur-Mer, France

Ch - Pierre Oudot

Bourgoin, France

Privee - Pasteur Lanroze

Brest, France

Cac - François Baclesse

Caen, France

Chu - Côte de Nacre

Caen, France

Ch - Jean Rougier

Cahors, France

Privee - Infirmerie Protestante

Caluire-et-Cuire, France

CH -

Carcassonne, France

Ch - Castres Mazamet Chi

Castres, France

Prive - Médipole de Savoie

Challes-les-Eaux, France

Prive - Sainte Marie

Chalon-sur-Saône, France

CH -

Cholet, France

Ch - Hopitaux Civils de Colmar

Colmar, France

Hopitaux civils de Colmar

Colmar, France

Chu - Louis Mourier

Colombes, France

Prive - Saint Côme

Compiègne, France

Prive - Cédres

Cornebarrieu, France

Chu - Henri Mondor

Créteil, France

Prive - Centre Leonard de Vinci

Dechy, France

Cac - Gf Leclerc

Dijon, France

Chu - Francois Mitterrand

Dijon, France

CH -

Dunkirk, France

CHI - Elbeuf Louviers Val de Reuil

Elbeuf, France

Clinique privée - CENTRE CARIO

Plérin, France