Back to resultsA 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
Primary Purpose
Lung Cancer
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Cisplatin+Vindesine+MMC/ concurrent radiation
Irinotecan+Carboplatin/concurrent radiation
Paclitaxel+Carboplatin/concurrent radiation
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer
Eligibility Criteria
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: 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. -
Sites / Locations
Outcomes
Primary Outcome Measures
Survival
Secondary Outcome Measures
safety
Full Information
NCT ID
NCT00144053
First Posted
August 31, 2005
Last Updated
January 5, 2006
Sponsor
West Japan Thoracic Oncology Group
1. Study Identification
Unique Protocol Identification Number
NCT00144053
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2005
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
West Japan Thoracic Oncology Group
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Cisplatin+Vindesine+MMC/ concurrent radiation
Intervention Type
Drug
Intervention Name(s)
Irinotecan+Carboplatin/concurrent radiation
Intervention Type
Drug
Intervention Name(s)
Paclitaxel+Carboplatin/concurrent radiation
Primary Outcome Measure Information:
Title
Survival
Secondary Outcome Measure Information:
Title
safety
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hisao Uejima, MD
Organizational Affiliation
West Japan Thoracic Oncology Group
Official's Role
Principal Investigator
12. IPD Sharing Statement
Links:
URL
http://www.wjtog.org/
Description
Related Info
Learn more about this trial
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
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