Combination Chemotherapy in Treating Older Patients With Solid Tumour,

GERCOR - Multidisciplinary Oncology Cooperative Group516 enrolled

Overview

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.

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

Allocation

Masking

NONE

Enrollment

516

Conditions

Solid Tumor Regardless of Localization and Stage

Interventions

chemotherapyOTHER

Eligibility

Sex: ALLMin age: 75 Years

Medical Language ↔ Plain English

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.

Locations (29)

Centre Radiotherapie Oncologie Moyenne Garonne

Outcomes

Primary Outcomes

chemotherapy feasibility

ability to deliver at least 3 months of the planned regimen therapy.

Time frame: 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)

dose reduction \< 33%

Time frame: 3 months

Secondary Outcomes

Grade 3-4 toxicities according to NCI-CTCAE version 3

Time frame: from inclusion to 3 months

Data from ClinicalTrials.gov

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