Combination Chemotherapy in Treating Older Patients With Solid Tumour,

NCT ID: NCT00664911

Last Updated: 2013-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

516 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2013-10-31

Brief Summary

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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

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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.

Conditions

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Solid Tumor Regardless of Localization and Stage

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Chemotherapy

chemotherapy regimen

Group Type OTHER

chemotherapy

Intervention Type OTHER

Interventions

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chemotherapy

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GERCOR - Multidisciplinary Oncology Cooperative Group

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elisabeth Carola, MD

Role: STUDY_CHAIR

C.H. Senlis

Locations

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Centre Radiotherapie Oncologie Moyenne Garonne

Agen, , France

Site Status

Centre Hospitalier de Castelluccio

Ajaccio, , France

Site Status

Centre Hospitalier d'Ardeche Meridionale

Aubenas, , France

Site Status

Centre Hospitalier d'Auxerre

Auxerre, , France

Site Status

Institut Sainte Catherine

Avignon, , France

Site Status

Hopital Duffaut

Avignon, , France

Site Status

Centre Hospitalier de Beauvais

Beauvais, , France

Site Status

Clinique des Cedres

Cornebarrieu, , France

Site Status

Centre Medico-Chirurgical et Obstetrique d'Evry

Évry, , France

Site Status

Hopital Clarac

Fort de France Cedex, , France

Site Status

Centre Hospitalier Intercommunal des Alpes du Sud

Gap, , France

Site Status

Centre Hospitalier de Lagny

Lagny-sur-Marne, , France

Site Status

Centre Hospitalier St. Joseph St. Luc

Lyon, , France

Site Status

Hopital Prive Jean Mermoz

Lyon, , France

Site Status

Centre Hospitalier Chanaux

Mâcon, , France

Site Status

Centre Hospitalier de Montelimar

Montélimar, , France

Site Status

Hopital Bichat - Claude Bernard

Paris, , France

Site Status

Hopital de la Croix St. Simon

Paris, , France

Site Status

Hopital Saint Antoine

Paris, , France

Site Status

Hopital Tenon

Paris, , France

Site Status

Hopital Rene Dubos

Pontoise, , France

Site Status

Institut Jean Godinot

Reims, , France

Site Status

Centre Hospitalier Prive Saint-Gregoire

Saint-Grégoire, , France

Site Status

Centre Hospitalier de Saint-Quentin

Saint-Quentin, , France

Site Status

Centre Hospitalier de Semur en Auxois

Semur-en-Auxois, , France

Site Status

C.H. Senlis

Senlis, , France

Site Status

Hopital Foch

Suresnes, , France

Site Status

Centre hospitalier de Tonnerre

Tonnerre, , France

Site Status

Centre Hospitalier Villeneuve Saint Georges

Villeneuve-Saint-Georges, , France

Site Status

Countries

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France

Other Identifiers

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GERCOR-OLD

Identifier Type: -

Identifier Source: secondary_id

EudraCT-2007004103-36

Identifier Type: -

Identifier Source: secondary_id

CDR0000593133

Identifier Type: -

Identifier Source: org_study_id