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

Phase 2
18 Years
Not Enrolling
Carcinoma, Non-Small-Cell Lung

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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:


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:


Principal Investigator

Klaus K Herfarth, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Heidelberg


Germany: Paul-Ehrlich-Institut

Study ID:

NEAR L-284/2004



Start Date:

May 2005

Completion Date:

August 2010

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms