Combination Chemotherapy in Treating Older Patients With Solid Tumour, (OLD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00664911
Recruitment Status : Completed
First Posted : April 23, 2008
Last Update Posted : October 16, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Solid Tumor Regardless of Localization and Stage Other: chemotherapy Phase 4

Detailed Description:



  • 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.


  • 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 516 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Study of a Scale Predicting the Feasibility of Chemotherapy in Patients Aged 75 Years or Older With Solid Tumour
Study Start Date : March 2008
Actual Primary Completion Date : April 2012
Actual Study Completion Date : October 2013

Arm Intervention/treatment
chemotherapy regimen
Other: chemotherapy

Primary Outcome Measures :
  1. chemotherapy feasibility [ Time Frame: from inclusion to 3 months ]
    ability to deliver at least 3 months of the planned regimen therapy.

  2. 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) [ Time Frame: 3 months ]
    dose reduction < 33%

Secondary Outcome Measures :
  1. Grade 3-4 toxicities according to NCI-CTCAE version 3 [ Time Frame: from inclusion to 3 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   75 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed solid tumour regardless of localization or stage


  • > or = 75 years
  • patient planned to receive > or = 2/3 of standard dose of the first cycle


Chemonaive patient.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00664911

Centre Radiotherapie Oncologie Moyenne Garonne
Agen, France, 47000
Centre Hospitalier de Castelluccio
Ajaccio, France, 20176
Centre Hospitalier d'Ardeche Meridionale
Aubenas, France, 07205
Centre Hospitalier d'Auxerre
Auxerre, France, 89011
Institut Sainte Catherine
Avignon, France, 84000
Hopital Duffaut
Avignon, France, 84902
Centre Hospitalier de Beauvais
Beauvais, France, 60021
Clinique des Cedres
Cornebarrieu, France, 31700
Centre Medico-Chirurgical et Obstetrique d'Evry
Evry, France, 91000
Hopital Clarac
Fort de France Cedex, France, 97261
Centre Hospitalier Intercommunal des Alpes du Sud
Gap, France, 05007
Centre Hospitalier de Lagny
Lagny Sur Marne, France, 77405
Centre Hospitalier St. Joseph St. Luc
Lyon, France, 69007
Hopital Prive Jean Mermoz
Lyon, France, 69008
Centre Hospitalier Chanaux
Macon, France, 71018
Centre Hospitalier de Montelimar
Montelimar, France, 26200
Hopital Bichat - Claude Bernard
Paris, France, 75018
Hopital de la Croix St. Simon
Paris, France, 75020
Hopital Saint Antoine
Paris, France, 75571
Hopital Tenon
Paris, France, 75970
Hopital Rene Dubos
Pontoise, France, 95300
Institut Jean Godinot
Reims, France, 51056
Centre Hospitalier Prive Saint-Gregoire
Saint-Gregoire, France, 35768
Centre Hospitalier de Saint-Quentin
Saint-Quentin, France, 02321
Centre Hospitalier de Semur en Auxois
Semur en Auxois, France, 21140
C.H. Senlis
Senlis, France, 60309
Hopital Foch
Suresnes, France, 92151
Centre hospitalier de Tonnerre
Tonnerre, France, 89700
Centre Hospitalier Villeneuve Saint Georges
Villeneuve Saint Georges, France, 94195
Sponsors and Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
Study Chair: Elisabeth Carola, MD C.H. Senlis

Responsible Party: GERCOR - Multidisciplinary Oncology Cooperative Group Identifier: NCT00664911     History of Changes
Other Study ID Numbers: CDR0000593133
First Posted: April 23, 2008    Key Record Dates
Last Update Posted: October 16, 2013
Last Verified: October 2013