Combination Chemotherapy in Treating Older Patients With Solid Tumour, (OLD)
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|ClinicalTrials.gov Identifier: NCT00664911|
Recruitment Status : Completed
First Posted : April 23, 2008
Last Update Posted : October 16, 2013
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|
- 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|
- chemotherapy feasibility [ Time Frame: from inclusion to 3 months ]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 ]dose reduction < 33%
- Grade 3-4 toxicities according to NCI-CTCAE version 3 [ Time Frame: from inclusion to 3 months ]
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 ClinicalTrials.gov identifier (NCT number): NCT00664911
|Study Chair:||Elisabeth Carola, MD||C.H. Senlis|