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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2010-08-31

Brief Summary

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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)

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Detailed Description

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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%

Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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cetuximab

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No