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Clinical Trial Summary

This non-randomized Phase I/II study is designed to determine the maximum tolerated dose (MTD) of thoracic radiotherapy and concurrent chemotherapy with cisplatin and docetaxel in patients with LA-NSCLC. All patients will receive weekly administrations of docetaxel 20 mg/m² and cisplatin 20 mg/m2 concurrently with radiotherapy. Radiotherapy will be delivered using helical tomotherapy in 30 daily fractions over six weeks. Patients should have recovered fully from induction concurrent chemoradiotherapy before they continue with the consolidation chemotherapy phase. Patients will be entered in cohorts of at least 5 subjects.

The first cohort of patients will receive 30 fractions of 2Gy in six weeks up to a total dose of 60Gy. The concurrent chemotherapy starts at day 1 of the radiotherapy and will be administered 2-4 hours before the radiotherapy.

The radiotherapy fraction size will be escalated to 2.36Gy in three steps.


Clinical Trial Description

Dose escalation steps are:

30*2.00Gy = 60.0Gy (BED= 70.8Gy10 NID2= 60.0Gy) 30*2.12Gy = 63.6Gy (BED= 75.9Gy10 NID2= 64.2Gy) 30*2.24Gy = 67.2Gy (BED= 81.5Gy10 NID2= 68.5Gy) 30*2.36Gy = 70.8Gy (BED= 86.3Gy10 NID2= 72.9Gy) If MTD is not reached, protocol modification allowing further escalation can be considered. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00379717
Study type Interventional
Source AZ-VUB
Contact Samuel Bral, MD
Phone 003224776415
Email samuel.bral@uzbrussel.be
Status Recruiting
Phase Phase 1/Phase 2
Start date November 2006
Completion date April 2008

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