Combination Chemotherapy in Treating Older Patients With Solid Tumour,

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00664911

Acronym

OLD

Enrollment

516

Registered

2008-04-23

Start date

2008-03-31

Completion date

2013-10-31

Last updated

2013-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumor Regardless of Localization and Stage

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.

Interventions

OTHERchemotherapy

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

75 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
chemotherapy feasibility	from inclusion to 3 months	ability to deliver at least 3 months of the planned regimen therapy.
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)	3 months	dose reduction \< 33%

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026