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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

W

West Japan Thoracic Oncology Group

Status and phase

Completed
Phase 3

Conditions

Lung Cancer

Treatments

Drug: Paclitaxel+Carboplatin/concurrent radiation
Drug: Irinotecan+Carboplatin/concurrent radiation
Drug: Cisplatin+Vindesine+MMC/ concurrent radiation

Study type

Interventional

Funder types

Other

Identifiers

NCT00144053
WJTOG0105

Details and patient eligibility

About

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

Sex

All

Ages

20 to 74 years old

Volunteers

No Healthy Volunteers

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. -

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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