NCT00293085

An Open, Randomized, Multicentre, Phase II Pilot Study

An Open, Randomized, Multicentre, Phase II Pilot Study of Docetaxel and Cisplatin in the Adjuvant Treatment of Non-Small Cell Lung Cancer (NSCLC) Stage I-II

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Central European Cooperative Oncology Group · Academic / Other
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate efficacy, safety and quality of life adjuvant docetaxel-cisplatin chemotherapy versus no adjuvant treatment in patients with completely resected NSCLC Stage I-II.

Detailed description

Open multicentre, centrally randomized, two-arm parallel-group, phase II pilot-study. Duration of the Treatment : Arm A - will be 4-6 cycles Docetaxel 75mg/m2 and Cisplatin 75mg/m2 on day 1 every 21 days. Arm B untreated control group - best supportive care. A follow-up check-up examination will be performed every 3 months for a total of three years.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel
DRUG	Docetaxel	Docetaxel (Taxotere) 75 mg/m² as a 1 hour i.v. infusion, followed immediately by cisplatin 75 mg/m² as a 1 hour i.v. infusion, on day 1 every 21 days for 6 cycles. Dose reductions and/or treatment delays or discontinuation of treatment are planned for arm A in case of severe haematological and/or non haematological toxicities. Premedication: Dexamethasone 8 mg p.o. (or any other steroid commonly used) will be given -12 h, -3 h, -1 h before start of docetaxel infusion, then + 12 h, +24 h and + 36 h post infusion. All patients should receive a prophylactic antiemetic premedication to prevent nausea and vomitus, which includes a 5-HT3 antagonist prior to start of each docetaxel infusion. Hyperhydration Patients will require intravenous hydration according to institutional guidelines.

Timeline

• Start date: 2001-12-01
• Completion: 2003-09-01
• First posted: 2006-02-17
• Last updated: 2011-06-23