NCT00379717

Concurrent Helical Tomotherapy With Chemotherapy in Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC)

Concurrent Helical Tomotherapy With Chemotherapy in Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC): a Phase I/II Trial of Radiation Dose Escalation and Fixed Dose Chemotherapy.

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Universitair Ziekenhuis Brussel · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Non-Small-Cell Lung Carcinoma

Interventions

Type	Name	Description
DRUG	Cisplatinum
DRUG	Docetaxel
DEVICE	Tomotherapy

Timeline

• Start date: 2006-11-01
• Completion: 2008-04-01
• First posted: 2006-09-22
• Last updated: 2008-03-13

Locations

1 site across 1 country: Belgium