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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

This study has been completed.
Sponsor:
Information provided by:
West Japan Thoracic Oncology Group
ClinicalTrials.gov Identifier:
NCT00144053
First received: August 31, 2005
Last updated: January 5, 2006
Last verified: August 2005
History of Changes
  Purpose

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


Condition Intervention Phase
Lung Cancer
 Drug: Cisplatin+Vindesine+MMC/ concurrent radiation
Drug: Irinotecan+Carboplatin/concurrent radiation
Drug: Paclitaxel+Carboplatin/concurrent radiation
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by West Japan Thoracic Oncology Group:

Primary Outcome Measures:
  • Survival

Secondary Outcome Measures:
  • safety

Estimated Enrollment: 450
Study Start Date: April 2001
  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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. -

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00144053

Sponsors and Collaborators
West Japan Thoracic Oncology Group
Investigators
Principal Investigator: Hisao Uejima, MD West Japan Thoracic Oncology Group
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00144053     History of Changes
Other Study ID Numbers: WJTOG0105
Study First Received: August 31, 2005
Last Updated: January 5, 2006
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Mitomycins
Mitomycin
Irinotecan
Cisplatin
Vindesine
 Carboplatin
Paclitaxel
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents

ClinicalTrials.gov processed this record on May 19, 2013