A randomized phase II study comparing cisplatin + docetaxel with carboplatin + paclitaxel in patients with Stage III (N 2 positive) non-small-cell lung cancer who receive trimodality treatment consisting of chemoradiotherapy followed by surgery (OLCSG1601)
- Conditions
- previously untreated non-small-cell lung ccancer, stage III (N2 positive)
- Registration Number
- JPRN-UMIN000024816
- Lead Sponsor
- Okayama Lung Cancer Study Group (OLCSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Not provided
(1) A case who has active double cancer. Even in case of metachronous double cancer (more than 5 years), patient with a history of chemotherapy or chest radiotherapy is excluded. (2) A case with severe drug allergy history. (3) Pregnant / lactating woman, a woman with an intention of pregnancy, a man with a partner who has an intention of pregnancy. (4) A case with severe complications such as the following. Active interstitial lung disease in chest X ray and CT Serious heart disease (difficult to control angina, myocardial infarction within 3 months, etc.) Diabetes mellitus difficult to control Serious infection Active hepatitis B, hepatitis C Other complications that are thought to have serious obstacles to the performance of treatment (5) A case with peripheral sensory neuropathy or peripheral motor neuropathy of more than grade 2. (6) A case that the doctor judged inappropriate.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2 year progression free survival rate
- Secondary Outcome Measures
Name Time Method Response rate of preoperative treatment, progression-free survival, 2-year survival rate, overall survival time, curative resection rate of surgery, completion rate of protocol treatment , adverse event