NCT00115518

Radiation Plus Cetuximab in Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

Locoregional Radiotherapy in Combination With Cetuximab in Inoperable Non-Small Cell Lung Cancer Stage III

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Heidelberg University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to study combined locoregional radiotherapy with cetuximab in non-operable NSCLC Stage III (Phase II trial). Endpoints: safety and feasibility (primary) response, survival, time to progression (secondary)

Detailed description

Study entry examinations: * blood cell count * liver enzymes * ventilatory function test * pregnancy test (premenopausal women) * CT of the thorax * CT of the brain * Ultrasound of the liver * Bone scan * FDG PET scan (after inclusion) Follow-up examinations (2 months, than every 3 months): * patients history and examination * CT scan of the thorax * ventilatory functions test * FDG PET scan (at least at 6 months) * bone scan (yearly) * ultrasound of the liver (every 6 months) Cetuximab administration: * 450 mg / m\^2 body surface on week 1 * 250 mg /m\^2 body surface weekly, week 2 -21 Radiation therapy: * intensity modulated radiation therapy of primary tumor and mediastinum (2 Gy single dose, total dose 50 Gy; 5 fractions per week) with boost to the PET positive sites (2 Gy single doses up to 66 Gy). Radiation therapy during weeks 2-8. Amendment 1/07: 3D conformal RT possible, but not if FeV1 \< 1.5L of \< 50%

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	cetuximab	After Cetuximab loading dose. weekly cetuximab during RT. 13 weeks cetuximab weekly maintenance

Timeline

• Start date: 2005-05-01
• Primary completion: 2009-06-01
• Completion: 2010-08-01
• First posted: 2005-06-23
• Last updated: 2011-08-05

Locations

1 site across 1 country: Germany