Carcinoma, Non-Small-Cell Lung
Conditions
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%
Interventions
DRUGcetuximab
After Cetuximab loading dose. weekly cetuximab during RT. 13 weeks cetuximab weekly maintenance
Sponsors
Heidelberg University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety: rate of side effects (skin reactions, allergic reactions, decrease of pulmonary function) | 3 yrs |
Secondary
| Measure | 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 |
Countries
Germany
Outcome results
None listed