CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 482 enrolled
Drug / intervention
cisplatin +1 moredrug
Likely dose
cisplatin 50 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00002583
NCT00002583Phase 3Completed
CompareCT.gov

A Phase III Prospective Randomized Study of Adjuvant Chemotherapy With Vinorelbine and Cisplatin in Completely Resected Non-Small Cell Lung Cancer With Companion Tumour Marker Evaluation

NCIC Clinical Trials Group·interventional·Posted Apr 22, 2004·Updated Apr 3, 2020

In Brief

A Phase 3 clinical trial evaluating cisplatin and vinorelbine ditartrate for Lung Cancer. Completed, enrolled 482 participants across 155 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesCanada, United States
CollaboratorsNational Cancer Institute (NCI), SWOG Cancer Research Network, Eastern Cooperative Oncology Group, Cancer and Leukemia Group B

Timeline

Phase 3CompletedFinished
1994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 22, 2004
Enrollment StartJul 7, 1994
Primary CompletionApr 25, 2004
Study CompletionDec 21, 2009
TodayJul 2, 2026
Enrollment to primary: 9.8 yearsPosted 22.2 years ago

Interventions

cisplatindrug

50 mg/m2 IV

vinorelbine ditartratedrug

25 mg/m2 IV