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Tarceva And Radiotherapy in Locally Advanced Lung Cancer Non-small Cell Lung Cancer (TARLAL)

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ClinicalTrials.gov Identifier: NCT00888511
Recruitment Status : Completed
First Posted : April 27, 2009
Last Update Posted : May 20, 2016
Odense University Hospital
Copenhagen University Hospital at Herlev
Rigshospitalet, Denmark
Aalborg Universitetshospital
Aarhus University Hospital
Naestved Hospital
Information provided by (Responsible Party):
Olfred Hansen, Odense University Hospital

Brief Summary:
The trial is a phase II study of daily Tarceva combined with definitive radiotherapy in inoperable locally advanced non small cell lung cancer (stage IIB-IIIB). The objective of the phase II trial is to examine Tarceva concomitant with curatively intended irradiation 66 Gy (2 Gy x 33 F, 5 F per week).

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Tarceva Radiation: Radiotherapy Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Concomitant Tarceva® and Irradiation in Patients in Local-regionally Advanced Non-small Cell Lung Cancer. A Phase II Study
Study Start Date : May 2009
Primary Completion Date : May 2016
Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Tarceva
Tarceva 150 mg/day
Radiation: Radiotherapy
66 Gy/33 F/5 F per week for 5 weeks

Primary Outcome Measures :
  1. Local failure free survival at 9 months after start of radiotherapy evaluated at CT scan [ Time Frame: May 2012 ]

Secondary Outcome Measures :
  1. Toxicity [ Time Frame: May 2012 ]
  2. Local tumor control by CT-scan [ Time Frame: May 2012 ]
  3. Overall response rate (CR + PR) [ Time Frame: May 2012 ]
  4. Local tumor control at 9 months evaluated by PET-CT [ Time Frame: May 2012 ]
  5. Overall survival [ Time Frame: May 2012 ]
  6. Disease free survival [ Time Frame: May 2012 ]
  7. Late toxicity [ Time Frame: May 2012 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age ≥18 years
  • Patients with histologically or cytologically documented diagnosis locally advanced NSCLC stage IIB to IIIB without pleural effusion
  • Performance status ≤2 on the ECOG scale
  • Serum bilirubin must be ≤1.5 upper limit of normal (ULN)
  • ALAT ≤2 x ULN
  • Able to comply with study and follow-up procedures
  • Patients with reproductive potential must use effective contraception
  • Written (signed) informed consent to participate in the study

Exclusion Criteria:

  • Any unstable systemic disease (including active infection, unstable angina, congestive heart failure, severe hepatic, renal, or metabolic disease)
  • Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer)
  • Inability to take oral medication, or requirement of intravenous alimentation
  • Nursing mothers

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 ClinicalTrials.gov identifier (NCT number): NCT00888511

Department of Oncology, Aarhus University Hospital
Aarhus, Denmark, 8000
Department of Oncology, Rigshospitalet
Copenhagen, Denmark, 2100
Department of Oncology, Copenhagen University Hospital at Herlev
Herlev, Denmark, 270
Department of Oncology, Naestved Hospital
Naestved, Denmark
Laboratory of Radiation Physics
Odense, Denmark, 5000
Odense University Hospital
Odense, Denmark, 5000
Department of Oncology, Vejle Hospital
Vejle, Denmark, 7100
Sponsors and Collaborators
Olfred Hansen
Odense University Hospital
Copenhagen University Hospital at Herlev
Rigshospitalet, Denmark
Aalborg Universitetshospital
Aarhus University Hospital
Naestved Hospital
Principal Investigator: Olfred Hansen, MD Odense University Hospital

Responsible Party: Olfred Hansen, MD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT00888511     History of Changes
Other Study ID Numbers: 09.02
First Posted: April 27, 2009    Key Record Dates
Last Update Posted: May 20, 2016
Last Verified: May 2016

Keywords provided by Olfred Hansen, Odense University Hospital:
Lung cancer
Non-small cell lung cancer
Local-regionally advanced non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action