Adjuvant cisplatin and vinorelbine in patients with completely resected pathological II-IIIA non-small cell lung cancer.

Phase 2

• Conditions: on-small cell lung cancer

• Registration Number: JPRN-UMIN000005055
• Lead Sponsor: Department of Thoracic Surgery, Kyoto University Hospital

Brief Summary

Purpose Adjuvant vinorelbine and cisplatin chemotherapy is recognized as a standard regimen for patients with completely resected stage II and III non-small cell lung cancer (NSCLC). However, efficacy of adjuvant chemotherapy in Japanese phase III trials with cisplatin-containing regimen has been controversial, and data are limited on the long-term outcome of adjuvant vinorelbine and cisplatin chemotherapy for NSCLC patients. Methods This was a single-arm phase II study in patients with completely resected pathological stage II or III NSCLC, who had not received prior chemotherapy or radiotherapy. Patients received 4 cycles of vinorelbine [25 mg/m2 of body surface area (BSA)] and cisplatin (40 mg/m2 of BSA) on days 1 and 8, every 4 weeks. Primary end point was the 3-year relapse-free survival; secondary end points were overall survival and safety. Results Between December 2006 and January 2011, 60 patients (40 men and 20 women, median age 64 years) were enrolled; all patients were evaluable for survival and safety. Three-year relapse-free survival rate was 55.0% (95% confidence interval 42.4-67.6%). Three- and five-year overall survival rates were 83.3 and 77.8%, respectively. There were no chemotherapy-related deaths, and adverse effects were acceptable. Conclusions Adjuvant vinorelbine and cisplatin chemotherapy was safe and showed a valid relapse-free survival rate. This regimen could be used as a standard regimen and deserves to be a control arm of trials on adjuvant chemotherapy in the Japanese NSCLC patient population.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-09
• Study Completion: 2015-12-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Patients receiving induction chemotherapy, radiotherapy for corresponding NSCLC Patients receiving other postoperative chemotherapy / radiotherapy (Pleurodesis with OK-432 is excluded.) Patients with other active malignancy. Patients with active infection. Patients with cardiac diseases which are not well-controlled. Patients with interstitial lung diseases. Patients with uncontrolled diabetes mellitus Patients with a disease which needs steroid treatment Patients who have allergy to CDDP or VNR Patients in pregnancy or during lactation

Study & Design

• Study Type: Interventional
• Study Design: Not specified