Phase I/II Study of Weekly Paclitaxel and Carboplatin with Concurrent Radiation Therapy in Locally Advanced Non-Small-Cell Lung Cancer. Kansai Clinical Oncology Group KCOG T-0401
Not Applicable
- Conditions
- ocally Advanced Non-Small-Cell Lung Cancer
- Registration Number
- JPRN-UMIN000026606
- Lead Sponsor
- Kansai Clinical Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
pulmonary fibrosis requiring oxygen therapy, myocardial infarction that occurred during the prior six months, liver cirrhosis, active haemorrhage of the digestive tract, mental disorder requiring treatment, diabetes mellitus in poor control, paresis of the intestine ileus, active infection, case with a history of radiation in the fields of radiation, allergy to polyoxyethylene component preparation, peripheral neuropathy, and pregnancy. Cases that a physician judged to be inadequate were also excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary end point of the phase I study was to determine a recommended dosage of paclitaxel during the concurrent chemoradiotherapy part. The primary endpoint of the phase II study was the response rate. Secondary endpoints were progression free survival, overall survival, and safety.
- Secondary Outcome Measures
Name Time Method