NCT00664911

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
516

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2008

Longer than P75 for phase_4

Geographic Reach
1 country

29 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 23, 2008

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

October 16, 2013

Status Verified

October 1, 2013

Enrollment Period

4.1 years

First QC Date

April 22, 2008

Last Update Submit

October 15, 2013

Conditions

Solid Tumor Regardless of Localization and Stage

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

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

    from inclusion to 3 months

Study Arms (1)

Chemotherapy

OTHER

chemotherapy regimen

Other: chemotherapy

Interventions

chemotherapyOTHER
Chemotherapy

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (29)

Centre Radiotherapie Oncologie Moyenne Garonne

Agen, 47000, France

Location

Centre Hospitalier de Castelluccio

Ajaccio, 20176, France

Location

Centre Hospitalier d'Ardeche Meridionale

Aubenas, 07205, France

Location

Centre Hospitalier d'Auxerre

Auxerre, 89011, France

Location

Institut Sainte Catherine

Avignon, 84000, France

Location

Hopital Duffaut

Avignon, 84902, France

Location

Centre Hospitalier de Beauvais

Beauvais, 60021, France

Location

Clinique des Cedres

Cornebarrieu, 31700, France

Location

Centre Medico-Chirurgical et Obstetrique d'Evry

Évry, 91000, France

Location

Hopital Clarac

Fort de France Cedex, 97261, France

Location

Centre Hospitalier Intercommunal des Alpes du Sud

Gap, 05007, France

Location

Centre Hospitalier de Lagny

Lagny-sur-Marne, 77405, France

Location

Centre Hospitalier St. Joseph St. Luc

Lyon, 69007, France

Location

Hopital Prive Jean Mermoz

Lyon, 69008, France

Location

Centre Hospitalier Chanaux

Mâcon, 71018, France

Location

Centre Hospitalier de Montelimar

Montélimar, 26200, France

Location

Hopital Bichat - Claude Bernard

Paris, 75018, France

Location

Hopital de la Croix St. Simon

Paris, 75020, France

Location

Hopital Saint Antoine

Paris, 75571, France

Location

Hopital Tenon

Paris, 75970, France

Location

Hopital Rene Dubos

Pontoise, 95300, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

Centre Hospitalier Prive Saint-Gregoire

Saint-Grégoire, 35768, France

Location

Centre Hospitalier de Saint-Quentin

Saint-Quentin, 02321, France

Location

Centre Hospitalier de Semur en Auxois

Semur-en-Auxois, 21140, France

Location

C.H. Senlis

Senlis, 60309, France

Location

Hopital Foch

Suresnes, 92151, France

Location

Centre hospitalier de Tonnerre

Tonnerre, 89700, France

Location

Centre Hospitalier Villeneuve Saint Georges

Villeneuve-Saint-Georges, 94195, France

Location

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Elisabeth Carola, MD

    C.H. Senlis

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2008

First Posted

April 23, 2008

Study Start

March 1, 2008

Primary Completion

April 1, 2012

Study Completion

October 1, 2013

Last Updated

October 16, 2013

Record last verified: 2013-10

Locations

FR(29)