Radiation Plus Cetuximab in Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

Heidelberg University30 enrolled

Overview

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)

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%

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

cetuximabDRUG

After Cetuximab loading dose. weekly cetuximab during RT. 13 weeks cetuximab weekly maintenance

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Heidelberg

Heidelberg, Germany

Outcomes

Primary Outcomes

safety: rate of side effects (skin reactions, allergic reactions, decrease of pulmonary function)

Time frame: 3 yrs

Secondary Outcomes

response (RECIST criteria of primary tumor and enlarged lymphnodes)

Time frame: 3 yrs

survival (at 3 years)

Time frame: 3 yrs

time to progression (locally and systemically)

Time frame: 3 yrs

Data from ClinicalTrials.gov

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