Prospective study of the efficacy and safety of chemotherapy for metastatic or progressive sarcomatoid carcinoma of the lung (carcinoma with pleomorphic, sarcomatoid, or sarcomatous elements) Hokkaido Lung Cancer Clinical Study Group Trial (HOT) 1201/North East Japan Study Group 024
- Conditions
- Metastatic or progressive sarcomatoid carcinoma of the lung (carcinoma with pleomorphic, sarcomatoid, or sarcomatous elements)
- Registration Number
- JPRN-UMIN000008707
- Lead Sponsor
- Hokkaido Lung Cancer Clinical Study Group North East Japan Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
1) Previous histories of drug allergy. 2) Serious concomitant infection. 3) Usages of oral steroids or immunosuppressive agents. 4) Serious complications including severe cardiovascular disease, cerebrovascular disease, severe hypertension, active peptic ulcer, or uncontrolled diabetes. 5) Interstitial pneumonia or pulmonary fibrosis on chest CT scans. 6) Severe pleural, abdominal, or cardiac effusion. 7) Major surgical procedures within 3 weeks or prior systemic therapy including radiotherapy within 2 weeks prior to study entry . 8) Patient in acknowledgment of hemoptysis (2.5 ml or more) or clinically important bleeding or a clot-related event. 9) Uncontrolled hypertension (systolic > 150 mmHg and/or diastolic > 90 mmHg). 10) Brain metastasis with uncontrollable symptoms. 11) Tumor permeation to chest great vessels. 12) Cavity in tumor. 13) Receiving anticoagulant drug (except aspirin under 325mg/day). 14) Patients with active concomitant malignancy. 15) Pregnant or lactating women. 16) Inappropriate patients judged by physicians.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate
- Secondary Outcome Measures
Name Time Method Progression-free survival Overall survival Safety