Locoregional Radiotherapy in Combination With Cetuximab in Inoperable Non-Small Cell Lung Cancer Stage III
18 Years
N/A
Both
Carcinoma, Non-Small-Cell Lung
Trial Information
Locoregional Radiotherapy in Combination With Cetuximab in Inoperable Non-Small Cell Lung Cancer Stage III
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%
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
safety: rate of side effects (skin reactions, allergic reactions, decrease of pulmonary function)
Outcome Time Frame:
3 yrs
Safety Issue:
Yes
Principal Investigator
Klaus K Herfarth, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Heidelberg
Authority:
Germany: Paul-Ehrlich-Institut
Study ID:
NEAR L-284/2004
NCT ID:
NCT00115518
Start Date:
May 2005
Completion Date:
August 2010
Related Keywords:
- Carcinoma, Non-Small-Cell Lung
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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