Radiation Plus Cetuximab in Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Registration Number
- NCT00115518
- Lead Sponsor
- Heidelberg University
- 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, 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%
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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%
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method safety: rate of side effects (skin reactions, allergic reactions, decrease of pulmonary function) 3 yrs
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
University of Heidelberg
🇩🇪Heidelberg, Germany