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CompletedNCT00144053Updated Jan 6, 2006

A Phase Ⅲ Randomized Study of Mitomycin/Vindesine/Cisplatin Versus Irinotecan/Carboplatin Versus Paclitaxel/Carboplatin With Concurrent Thoracic Radiotherapy for Unresectable Stage Ⅲ Non-Small-Cell Lung Cancer

A Phase 3 interventional study of Cisplatin+Vindesine+MMC/ concurrent radiation and Irinotecan+Carboplatin/concurrent radiation in Lung Cancer, sponsored by West Japan Thoracic Oncology Group. Completed. Open to participants aged 20 Years to 74 Years. Per ClinicalTrials.gov, last updated 2006-01-06.

Sponsored by West Japan Thoracic Oncology Group · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
450
Allocation
Randomized
Ages
20 Years to 74 Years
Sex
All
01

Study summary

To evaluate whether two weekly concurrent chemoradiotherapy regimens offer any advantage over concurrent chemoradiotherapy regimens with Cisplatin, Vindesine, Mitomycin for unresectable stage III NSCLC.

02

Conditions studied

  • Lung Cancer

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03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 450 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

West Japan Thoracic Oncology Group is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

All patients had histologically or cytologically confirmed locally advanced NSCLC. All patients must not have undergone any previous therapy for NSCLC. Patients had to have measurable disease, an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and to be less than 75 years old. Adequate organ (bone marrow, renal, liver, heart, and lung) function was required. All patients gave written informed consent.

Exclusion criteria

Exclusion Criteria:

The exclusion criteria consisted of pulmonary fibrosis, pleural effusion, pregnancy, lactation, active concurrent malignancies, severe drug allergies, myocardial infarction, severe heart disease, uncontrollable diabetes mellitus, and infection. -

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
450 participants

Interventions

  • DrugCisplatin+Vindesine+MMC/ concurrent radiation
  • DrugIrinotecan+Carboplatin/concurrent radiation
  • DrugPaclitaxel+Carboplatin/concurrent radiation
06

What researchers measure

Primary outcomes

  1. Survival

Secondary outcomes

  1. safety

07

Study locations

No study locations are listed for this record.

08

References and documents

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00144053
Lead sponsor
West Japan Thoracic Oncology Group
First posted
Sep 2, 2005
Start date
Apr 2001
Last update
Jan 6, 2006

Study contacts

Hisao Uejima, MD
principal investigator · West Japan Thoracic Oncology Group
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2005. You cannot join it, but the record below documents what was studied.

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