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IFCT-GFPC 05.02 A Randomized Phase III Trial Assessing in Patients With Advanced Non-small Cell Lung Cancer

NCT00300586 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 842

Last updated 2019-05-28

No results posted yet for this study

Summary

The objective of this trial is to improve the duration of control disease for PS 0-1 patients who are not progressing on first-line cisplatin-gemcitabine chemotherapy. Standard therapy is for these patients to stop first-line chemotherapy after 4 to 6 cycles and to begin a second-line chemotherapy when progression of disease is occurring. Two approaches will be experimented in this trial in attempt to prolong progression free survival :

* Maintenance chemotherapy with single-agent gemcitabine continued till disease progression or toxicity.
* Sequential treatment with erlotinib immediately given after the end of first-line chemotherapy.

Conditions

  • Stage IV Non-small Cell Lung Cancer

Interventions

DRUG

observation

observation, second line chemotherapy if progression

DRUG

gemcitabine

1250 mg/m² D1, D8 q21 days

DRUG

erlotinib

150 mg daily

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Maurice Pérol, MD · Hospices Civils de Lyon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00300586 on ClinicalTrials.gov