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

UMIN ID: C000000210

Registered date:15/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Completely resected p-IB-IIIA non-small cell lung cancer
• Date of first enrollment: 2005/07/01
• Target sample size: 150
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Adjuvant chemotherapy with carboplatin (6AUC) + paclitaxel (70mg/m2 x 3 week) x 4 courses is given to p-stage IB-IIIA non-small cell lung cancer patients whose tumors show moderate or high sensitivity to these drugs in collagen gel droplet embedded culture drug sensitivity test (CD-DST).

Outcome(s)

• Primary Outcome: Disease free survival
• Secondary Outcome: Overall Survival Toxicity

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Department of General Thoracic Surgery, Osaka University Graduate School of Medicine
• Source(s) of Monetary Support: Department of General Thoracic Surgery, Osaka University Graduate School of Medicine