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OpenTrials
Completed

NCT Number: NCT00664911

Combination Chemotherapy in Treating Older Patients 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.

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Key information

Conditions

Solid Tumor Regardless of Localization and Stage

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre Radiotherapie Oncologie Moyenne Garonne, Agen, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

chemotherapy

Other

Primary outcomes

  1. chemotherapy feasibility

    Time frame: from inclusion to 3 months

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

  2. 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)

    Time frame: 3 months

    dose reduction < 33%

Secondary outcomes

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

    Time frame: from inclusion to 3 months

Sponsors and collaborators

Lead sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group

Other

Registry information

Official study title

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

Acronym: OLD

Important dates

Study start
2008
Primary completion
2012
Study completion
2013
First posted
Apr 23, 2008
Registry last updated
Oct 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.