Status:
COMPLETED
Radiation Plus Cetuximab in Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Heidelberg University
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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, surviv...
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00115518
Start Date
May 1 2005
End Date
August 1 2010
Last Update
August 5 2011
Active Locations (1)
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1
University of Heidelberg
Heidelberg, Germany, 69120