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Chemotherapy or Observation in Treating Patients With Early Stage Non-Small Cell Lung Cancer

NCT00863512 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2017-03-27

Study results available
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Summary

RATIONALE: Drugs used in chemotherapy, such as vinorelbine, cisplatin, docetaxel, gemcitabine, and pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sometimes after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether chemotherapy is more effective than observation in treating patients who have undergone surgery for stage I non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying four chemotherapy regimens to see how well they work compared with observation in treating patients with early stage non-small cell lung cancer.

Conditions

Interventions

DRUG

cisplatin

Given IV

DRUG

docetaxel

Given IV

DRUG

gemcitabine hydrochloride

Given IV

DRUG

pemetrexed disodium

Given IV

DRUG

vinorelbine tartrate

Given IV

PROCEDURE

standard follow-up care

Standard care

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Alliance for Clinical Trials in Oncology

    lead OTHER

Principal Investigators

  • David H. Harpole, MD · Duke Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-11-30
Completion
2012-11-30

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00863512 on ClinicalTrials.gov