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Vinorelbine + Cisplatin or No Further Therapy in Non-small Cell Lung Cancer That Has Been Surgically Removed

NCT00002583 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 482

Last updated 2020-04-03

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if combination chemotherapy is more effective than no further treatment for non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of vinorelbine plus cisplatin with that of no further therapy in treating patients who have stage I or stage II non-small cell lung cancer that has been completely removed during surgery.

Conditions

Interventions

DRUG

cisplatin

50 mg/m2 IV

DRUG

vinorelbine ditartrate

25 mg/m2 IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • SWOG Cancer Research Network

    collaborator NETWORK

  • Eastern Cooperative Oncology Group

    collaborator NETWORK

  • Cancer and Leukemia Group B

    collaborator NETWORK

  • NCIC Clinical Trials Group

    lead NETWORK

Principal Investigators

  • Timothy L. Winton, MD · University of Alberta

  • Eric Vallieres, MD, FRCSC · University of Washington

  • Russell F. DeVore, MD · Vanderbilt-Ingram Cancer Center

  • James R. Rigas, MD · Norris Cotton Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
1994-07-07
Primary Completion
2004-04-25
Completion
2009-12-21
FDA Drug
Yes

Countries

  • United States
  • Canada

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 NCT00002583 on ClinicalTrials.gov