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

October 15, 2013 updated by: GERCOR - Multidisciplinary Oncology Cooperative Group

Study of a Scale Predicting the Feasibility of Chemotherapy in Patients Aged 75 Years or Older With Solid Tumour

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

516

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Chemotherapy
chemotherapy regimen
Other: chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
chemotherapy feasibility
Time Frame: from inclusion to 3 months
ability to deliver at least 3 months of the planned regimen therapy.
from inclusion to 3 months
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%
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Grade 3-4 toxicities according to NCI-CTCAE version 3
Time Frame: from inclusion to 3 months
from inclusion to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (ACTUAL)

April 1, 2012

Study Completion (ACTUAL)

October 1, 2013

Study Registration Dates

First Submitted

April 22, 2008

First Submitted That Met QC Criteria

April 22, 2008

First Posted (ESTIMATE)

April 23, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

October 16, 2013

Last Update Submitted That Met QC Criteria

October 15, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000593133
  • GERCOR-OLD
  • EudraCT-2007004103-36

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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