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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00115518
Recruitment Status : Completed
First Posted : June 23, 2005
Last Update Posted : August 5, 2011
Information provided by:
Heidelberg University

Brief Summary:

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 or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: cetuximab Phase 2

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%

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Locoregional Radiotherapy in Combination With Cetuximab in Inoperable Non-Small Cell Lung Cancer Stage III
Study Start Date : May 2005
Actual Primary Completion Date : June 2009
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab
U.S. FDA Resources

Intervention Details:
    Drug: cetuximab
    After Cetuximab loading dose. weekly cetuximab during RT. 13 weeks cetuximab weekly maintenance

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

Secondary Outcome Measures :
  1. response (RECIST criteria of primary tumor and enlarged lymphnodes) [ Time Frame: 3 yrs ]
  2. survival (at 3 years) [ Time Frame: 3 yrs ]
  3. time to progression (locally and systemically) [ Time Frame: 3 yrs ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00115518

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

Publications of Results:
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
First Posted: June 23, 2005    Key Record Dates
Last Update Posted: August 5, 2011
Last Verified: February 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