Clinical trial NCT00664911: Combination Chemotherapy in Treating Older Patients With Solid Tumour,
Official title: Study of a Scale Predicting the Feasibility of Chemotherapy in Patients Aged 75 Years or Older With Solid Tumour
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Solid Tumor Regardless of Localization and Stage
Lead sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group
Sponsor class: OTHER
First posted: 2008-04-23
Enrollment: 516
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_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.

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 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.

Primary outcomes:
measure: chemotherapy feasibility
timeFrame: from inclusion to 3 months
measure: 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)
timeFrame: 3 months
Secondary outcomes:
measure: Grade 3-4 toxicities according to NCI-CTCAE version 3
timeFrame: from inclusion to 3 months
Other outcomes:
Locations:
city: Agen
country: France
facility: Centre Radiotherapie Oncologie Moyenne Garonne
city: Ajaccio
country: France
facility: Centre Hospitalier de Castelluccio
city: Aubenas
country: France
facility: Centre Hospitalier d'Ardeche Meridionale
city: Auxerre
country: France
facility: Centre Hospitalier d'Auxerre
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Avignon
country: France
facility: Hopital Duffaut
city: Beauvais
country: France
facility: Centre Hospitalier de Beauvais
city: Cornebarrieu
country: France
facility: Clinique des Cedres
city: Evry
country: France
facility: Centre Medico-Chirurgical et Obstetrique d'Evry
city: Fort de France Cedex
country: France
facility: Hopital Clarac
city: Gap
country: France
facility: Centre Hospitalier Intercommunal des Alpes du Sud
city: Lagny Sur Marne
country: France
facility: Centre Hospitalier de Lagny
city: Lyon
country: France
facility: Centre Hospitalier St. Joseph St. Luc
city: Lyon
country: France
facility: Hopital Prive Jean Mermoz
city: Macon
country: France
facility: Centre Hospitalier Chanaux
city: Montelimar
country: France
facility: Centre Hospitalier de Montelimar
city: Paris
country: France
facility: Hopital Bichat - Claude Bernard
city: Paris
country: France
facility: Hopital de la Croix St. Simon
city: Paris
country: France
facility: Hopital Saint Antoine
city: Paris
country: France
facility: Hopital Tenon
city: Pontoise
country: France
facility: Hopital Rene Dubos
city: Reims
country: France
facility: Institut Jean Godinot
city: Saint-Gregoire
country: France
facility: Centre Hospitalier Prive Saint-Gregoire
city: Saint-Quentin
country: France
facility: Centre Hospitalier de Saint-Quentin
city: Semur en Auxois
country: France
facility: Centre Hospitalier de Semur en Auxois
city: Senlis
country: France
facility: C.H. Senlis
city: Suresnes
country: France
facility: Hopital Foch
city: Tonnerre
country: France
facility: Centre hospitalier de Tonnerre
city: Villeneuve Saint Georges
country: France
facility: Centre Hospitalier Villeneuve Saint Georges
Study officials:
affiliation: C.H. Senlis
name: Elisabeth Carola, MD
role: STUDY_CHAIR
References: