Phase I trial of biweekly Carboplatin plus nab-Paclitaxel with concurrent thoracic radiotherapy in patients with locally advanced non-small cell lung cancer
- Conditions
- on-small cell lung cancer
- Registration Number
- JPRN-UMIN000010480
- Lead Sponsor
- Aomori Prefectural Central Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 18
Not provided
1) Patients with T3N1. 2) Superior vena cava syndrome. 3) Contralateral hilar lymph node metastasis, malignant plueral, pericardial effusion, carcinomatous lymphangiosis. 4) Active double cancer. 5) Active infections requiring systemic treatment. 6) Severe concurrent disease (Pulmonary fibrosis or interstitial pneumonia, renal failure, hepatic failure, cerebrovascular disease, ischemic heart disease requiring treatment, arrhythmia, cardiac infarction within 6 months before enrollment, hemorrhagic peptic ulcer, poorly controlled diabetes). 7) Grade 2 or higher peripheral neuropathy. 8) Positive HBs antigen and/or HCV antibody. 9) History of Severe drug allergies. 10) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy. 11) Physician concludes that the patient's participation in this trial is inappropriate.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of dose limiting toxicities at each dose level
- Secondary Outcome Measures
Name Time Method Incidence and Severity of Adverse Events Treatment completion rate Response Rate 2-year survival rate Progression-free Survival Overall Survival