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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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 516 participants
Allocation: N/A
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

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Ages Eligible for Study:   75 Years and older   (Older Adult)
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

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Sponsors and Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
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Study Chair: Elisabeth Carola, MD C.H. Senlis
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Responsible Party: GERCOR - Multidisciplinary Oncology Cooperative Group Identifier: NCT00664911    
Other Study ID Numbers: CDR0000593133
First Posted: April 23, 2008    Key Record Dates
Last Update Posted: October 16, 2013
Last Verified: October 2013
Additional relevant MeSH terms:
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