Clinical trial of postoperative adjuvant chemotherapy with carboplatin/paclitaxel according to the results of collagen gel droplet embedded culture drug sensitivity test (CD-DST) in completely resected non-small-cell lung cancer

Phase 2

• Conditions: Completely resected p-IB-IIIA non-small cell lung cancer

• Registration Number: JPRN-C000000210
• Lead Sponsor: Department of General Thoracic Surgery, Osaka University Graduate School of Medicine

Brief Summary

The chemosensitivity to carboplatin and/or paclitaxel was 76%. The 5-year OS rates were 71, 73, and 75% for all, CD-DST success, and chemosensitive patients, respectively. The 5-year DFS and OS rates of the chemosensitive patients who completed adjuvant chemotherapy using carboplatin/paclitaxel were 68 and 82%, respectively. The 5-year DFS and OS rates of the patients with stage II-IIIA chemosensitive NSCLC were 58 and 75%, respectively.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-15
• Study Completion: 2015-05-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

Not provided

Exclusion Criteria

1, Heart diseases required treatment. 2, Myocardial infarction within 6 months. 3, Liver cirrhosis. 4, Symptomatic interstitial pneumonia or pulmonary fibrosis proven in the chest X-ray. 5, Active bowel hemorrhage required repeated transfusion. 6, Uncontrollable diabetes mellitus. 7, Ileus or subileus. 8, Active infection. 9, Peripheral neuropathy. 10, Psychological disorder required medication. 11, Drug allergy against cremophor EL(polyoxethylated castor oil). 12, During pregnancy or lactation. 13, Inadequate condition diagnosed by the primary physician.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease free survival

Secondary Outcome Measures

Name	Time	Method
Overall Survival Toxicity