A randomized phase II trial of induction CDDP +PEM +BEV versus CDDP + PEM with concurrent radiotherapy followed by surgical resection in patients with pathologically confirmed stage IIIA-N2 non-squamous- cell non-small cell lung cancer
- Conditions
- Stage IIIA-N2 Non-squamous, Non-small cell lung cancer
- Registration Number
- JPRN-UMIN000011941
- Lead Sponsor
- Advanced Clinical Trial chest surgery Group (ACTG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 80
Not provided
"1.Uncontrollable systemic disease.hyper tension, diabetes mellitus etc. 2. Current history of hemosputum or hemoptysis 3. Evidence of bleeding diathesis or coagulopathy 4. Cavity in lung tumor or great vessel involvement 5. Current or previous within the last 1 year history of cerebrovascular disease 6. Traumatic fracture of un recovery 7. History of active infection 8. hepatitis B surface antigen positive 9. Therapeutic anticoagulation; regular use of aspirin ,over 325 mg/day. 10. Severe GI disease 11. Current or previous within the last 1 year history of GI perforation or diverticultis 12. History of severe heart disease 13. Severe diarrhea 14. Severe drug allergy 15. Investigational new drug or the unapproved drug is administered 16. Interstitial pneumonia or pulmonary fibrosis detectable on chest Xp 17. History of active double cancer 18. History of pregnancy or lactation 19. Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator "
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2-year progression-free survival
- Secondary Outcome Measures
Name Time Method 5-year progression-free survival 2-year and 5-year overall survival Completion rate of the protocol treatment Complete resection rate Radiological response rate Down staging rate Safety Pathological response (Ef) Tumor markers (CEA/CYFRA) SUVmax on FDG-PET scan