Combination Chemotherapy in Treating Older Patients With Solid Tumour, (OLD)

Study of a Scale Predicting the Feasibility of Chemotherapy in Patients Aged 75 Years or Older With Solid Tumour

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.

Study Overview

• Status: Completed
• Conditions: Solid Tumor Regardless of Localization and Stage
• Intervention / Treatment: Other: chemotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 516
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Agen, France, 47000
    • Centre Radiotherapie Oncologie Moyenne Garonne
  • Ajaccio, France, 20176
    • Centre Hospitalier de Castelluccio
  • Aubenas, France, 07205
    • Centre Hospitalier d'Ardèche Méridionale
  • Auxerre, France, 89011
    • Centre Hospitalier D'Auxerre
  • Avignon, France, 84000
    • Institut Sainte Catherine
  • Avignon, France, 84902
    • Hopital Duffaut
  • Beauvais, France, 60021
    • Centre Hospitalier de Beauvais
  • Cornebarrieu, France, 31700
    • Clinique des Cèdres
  • Evry, France, 91000
    • Centre Medico-Chirurgical et Obstetrique d'Evry
  • Fort de France Cedex, France, 97261
    • Hopital Clarac
  • Gap, France, 05007
    • Centre Hospitalier Intercommunal des Alpes du Sud
  • Lagny Sur Marne, France, 77405
    • Centre Hospitalier de Lagny
  • Lyon, France, 69008
    • Hôpital privé Jean Mermoz
  • Lyon, France, 69007
    • Centre Hospitalier St. Joseph St. Luc
  • Macon, France, 71018
    • Centre Hospitalier Chanaux
  • Montelimar, France, 26200
    • Centre Hospitalier de Montelimar
  • Paris, France, 75018
    • Hopital Bichat - Claude Bernard
  • Paris, France, 75970
    • Hôpital Tenon
  • Paris, France, 75571
    • Hopital Saint Antoine
  • Paris, France, 75020
    • Hopital de la Croix St. Simon
  • Pontoise, France, 95300
    • Hôpital René Dubos
  • Reims, France, 51056
    • Institut Jean Godinot
  • Saint-Gregoire, France, 35768
    • Centre hospitalier Privé Saint-Grégoire
  • Saint-Quentin, France, 02321
    • Centre Hospitalier de Saint-Quentin
  • Semur en Auxois, France, 21140
    • Centre Hospitalier de Semur en Auxois
  • Senlis, France, 60309
    • C.H. Senlis
  • Suresnes, France, 92151
    • Hôpital Foch
  • Tonnerre, France, 89700
    • Centre hospitalier de Tonnerre
  • Villeneuve Saint Georges, France, 94195
    • Centre Hospitalier Villeneuve Saint Georges

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Chemotherapy; chemotherapy regimen	Other: chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
chemotherapy feasibility	ability to deliver at least 3 months of the planned regimen therapy.	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%	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Grade 3-4 toxicities according to NCI-CTCAE version 3	from inclusion to 3 months

Collaborators and Investigators

• Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (ACTUAL): April 1, 2012
• Study Completion (ACTUAL): October 1, 2013

Study Registration Dates

• First Submitted: April 22, 2008
• First Submitted That Met QC Criteria: April 22, 2008
• First Posted (ESTIMATE): April 23, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): October 16, 2013
• Last Update Submitted That Met QC Criteria: October 15, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CDR0000593133; GERCOR-OLD; EudraCT-2007004103-36