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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
ClinicalTrials.gov Identifier:
NCT00664911
First received: April 22, 2008
Last updated: October 15, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Solid Tumor Regardless of Localization and Stage
Other: chemotherapy
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Study of a Scale Predicting the Feasibility of Chemotherapy in Patients Aged 75 Years or Older With Solid Tumour

Resource links provided by NLM:


Further study details as provided by Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR):

Primary Outcome Measures:
  • chemotherapy feasibility [ Time Frame: from inclusion to 3 months ] [ Designated as safety issue: No ]
    ability to deliver at least 3 months of the planned regimen therapy.

  • 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 ] [ Designated as safety issue: Yes ]
    dose reduction < 33%


Secondary Outcome Measures:
  • Grade 3-4 toxicities according to NCI-CTCAE version 3 [ Time Frame: from inclusion to 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 516
Study Start Date: March 2008
Study Completion Date: October 2013
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Chemotherapy
chemotherapy regimen
Other: chemotherapy

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.

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed solid tumour regardless of localization or stage

PATIENT CHARACTERISTICS:

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

PRIOR CONCURRENT THERAPY:

Chemonaive patient.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00664911

Locations
France
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
Hopital Prive Jean Mermoz
Lyon, France, 69008
Centre Hospitalier St. Joseph St. Luc
Lyon, France, 69007
Centre Hospitalier Chanaux
Macon, France, 71018
Centre Hospitalier de Montelimar
Montelimar, France, 26200
Hopital Bichat - Claude Bernard
Paris, France, 75018
Hopital Saint Antoine
Paris, France, 75571
Hopital Tenon
Paris, France, 75970
Hopital de la Croix St. Simon
Paris, France, 75020
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
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Investigators
Study Chair: Elisabeth Carola, MD C.H. Senlis
  More Information

Additional Information:
No publications provided

Responsible Party: Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
ClinicalTrials.gov Identifier: NCT00664911     History of Changes
Other Study ID Numbers: CDR0000593133, GERCOR-OLD, EudraCT-2007004103-36
Study First Received: April 22, 2008
Last Updated: October 15, 2013
Health Authority: France: Committee for the Protection of Personnes

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014