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.

Sponsored by:	West Japan Thoracic Oncology Group
Information provided by:	West Japan Thoracic Oncology Group
ClinicalTrials.gov Identifier:	NCT00144053

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 III

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Cisplatin Irinotecan Irinotecan hydrochloride Paclitaxel Vindesine Mitomycin Mitomycins

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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

Related Info This link exits the ClinicalTrials.gov site

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

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Irinotecan
Vindesine
Carboplatin
Mitomycins
Carcinoma
Cisplatin

Respiratory Tract Diseases
Lung Neoplasms
Paclitaxel
Lung Diseases
Mitomycin
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Mitosis Modulators
Enzyme Inhibitors
Antimitotic Agents

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009