Combination Chemotherapy in Treating Older Patients With Solid Tumour,

Phase 4

Completed

• Conditions: Solid Tumor Regardless of Localization and Stage
• Interventions: Other: chemotherapy

• Registration Number: NCT00664911
• Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This clinical trial is studying how well combination chemotherapy works in treating older patients with solid tumour.

Detailed Description

OBJECTIVES:

Primary

* To determine a prognostic scale of the feasibility of chemotherapy (at least two-thirds of the dose intensity usually administered) in patients aged 75 years or older with solid tumour.

Secondary

* To evaluate the efficacy, in terms of clinical and/or biological response, of treatments administered.

* To evaluate the incidence of severe (grade 3-4) toxicity.

OUTLINE: This is a multicenter study. Patients receive one of the following regimens according to cancer diagnosis and principal investigator preference. All regimens last 3 months.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-04-22
• Study First Submitted QC: 2008-04-22
• Study First Posted: 2008-04-23
• Primary Completion: 2012-04
• Status Verified: 2013-10
• Study Completion: 2013-10
• Last Update Submitted: 2013-10-15
• Last Update Posted: 2013-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 516

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chemotherapy	chemotherapy	chemotherapy regimen

Primary Outcome Measures

Name	Time	Method
Number of patients receiving therapeutic dose-intensive therapy (doses must be at least equivalent to two-thirds the dose that is usually administered according to AMM recommendations)	3 months	dose reduction \< 33%
chemotherapy feasibility	from inclusion to 3 months	ability to deliver at least 3 months of the planned regimen therapy.

Secondary Outcome Measures

Name	Time	Method
Grade 3-4 toxicities according to NCI-CTCAE version 3	from inclusion to 3 months

Trial Locations

Locations (29)

Centre Hospitalier d'Ardeche Meridionale; 🇫🇷 Aubenas, France

Centre Hospitalier d'Auxerre; 🇫🇷 Auxerre, France

Hopital Duffaut; 🇫🇷 Avignon, France

Clinique des Cedres; 🇫🇷 Cornebarrieu, France

Centre Hospitalier de Beauvais; 🇫🇷 Beauvais, France

Centre Hospitalier de Castelluccio; 🇫🇷 Ajaccio, France

Institut Sainte Catherine; 🇫🇷 Avignon, France

Centre Hospitalier St. Joseph St. Luc; 🇫🇷 Lyon, France

Centre Radiotherapie Oncologie Moyenne Garonne; 🇫🇷 Agen, France

Hopital Clarac; 🇫🇷 Fort de France Cedex, France

Centre Medico-Chirurgical et Obstetrique d'Evry; 🇫🇷 Evry, France

Hopital Prive Jean Mermoz; 🇫🇷 Lyon, France

Centre hospitalier de Tonnerre; 🇫🇷 Tonnerre, France

C.H. Senlis; 🇫🇷 Senlis, France

Centre Hospitalier de Semur en Auxois; 🇫🇷 Semur en Auxois, France

Centre Hospitalier Chanaux; 🇫🇷 Macon, France

Centre Hospitalier Intercommunal des Alpes du Sud; 🇫🇷 Gap, France

Centre Hospitalier de Lagny; 🇫🇷 Lagny Sur Marne, France

Hopital Bichat - Claude Bernard; 🇫🇷 Paris, France

Centre Hospitalier de Montelimar; 🇫🇷 Montelimar, France

Hopital Saint Antoine; 🇫🇷 Paris, France

Hopital de la Croix St. Simon; 🇫🇷 Paris, France

Hopital Tenon; 🇫🇷 Paris, France

Centre Hospitalier de Saint-Quentin; 🇫🇷 Saint-Quentin, France

Centre Hospitalier Prive Saint-Gregoire; 🇫🇷 Saint-Gregoire, France

Hopital Rene Dubos; 🇫🇷 Pontoise, France

Institut Jean Godinot; 🇫🇷 Reims, France

Centre Hospitalier Villeneuve Saint Georges; 🇫🇷 Villeneuve Saint Georges, France

Hopital Foch; 🇫🇷 Suresnes, France