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

This study has been completed.
Information provided by:
Heidelberg University Identifier:
First received: June 22, 2005
Last updated: August 3, 2011
Last verified: February 2011

The purpose of this trial is to study combined locoregional radiotherapy with cetuximab in non-operable NSCLC Stage III (Phase II trial).


safety and feasibility (primary) response, survival, time to progression (secondary)

Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: cetuximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Locoregional Radiotherapy in Combination With Cetuximab in Inoperable Non-Small Cell Lung Cancer Stage III

Resource links provided by NLM:

Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • safety: rate of side effects (skin reactions, allergic reactions, decrease of pulmonary function) [ Time Frame: 3 yrs ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: May 2005
Study Completion Date: August 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: cetuximab
    After Cetuximab loading dose. weekly cetuximab during RT. 13 weeks cetuximab weekly maintenance
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%


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00115518

University of Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Principal Investigator: Klaus K Herfarth, MD Heidelberg University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Klaus Herfarth, MD, UJniversity of Heidelberg Identifier: NCT00115518     History of Changes
Other Study ID Numbers: NEAR L-284/2004
Study First Received: June 22, 2005
Last Updated: August 3, 2011

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents processed this record on April 21, 2017