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

Study Overview
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Brief Summary
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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
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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%

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

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Drug: cetuximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically verified NSCLC Not eligible for Radiochemotherapy or patient refuses chemotherapy FeV1 >1.5 L or min. 50% KPI >= 70% Life expectancy > 6 months Weight loss less than 10% of body weight in 12 months Compliance Adequate blood counts (LC > 3000 x 10^3/ml, Tc >100000 x 10^3/ml, Hb > 10 g/dl) Effective contraception Amendment 1/07: FeV1 >1.2 L or min 40% Exclusion Criteria: Active infection Reduced liver function Vena cava superior syndrome Malignant pleural effusion Pregnancy or breast feeding Additional serious systemic disease Secondary malignancy (except carcinoma in situ of the cervix, basalioma of the skin, secondary cancer in remission for > 5 years) Known allergies against proteins History of former antibody therapy Allergy against i.v. contrast agents

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cetuximab|After Cetuximab loading dose. weekly cetuximab during RT. 13 weeks cetuximab weekly maintenance|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety: rate of side effects (skin reactions, allergic reactions, decrease of pulmonary function) |  | 3 yrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response (RECIST criteria of primary tumor and enlarged lymphnodes) |  | 3 yrs | 
| survival (at 3 years) |  | 3 yrs | 
| time to progression (locally and systemically) |  | 3 yrs |