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

This study has been completed.
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT00888511
First received: April 24, 2009
Last updated: May 19, 2016
Last verified: May 2016
  Purpose
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 Intervention Phase
Non-small Cell Lung Cancer
Drug: Tarceva
Radiation: Radiotherapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Local failure free survival at 9 months after start of radiotherapy evaluated at CT scan [ Time Frame: May 2012 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: May 2012 ] [ Designated as safety issue: Yes ]
  • Local tumor control by CT-scan [ Time Frame: May 2012 ] [ Designated as safety issue: No ]
  • Overall response rate (CR + PR) [ Time Frame: May 2012 ] [ Designated as safety issue: No ]
  • Local tumor control at 9 months evaluated by PET-CT [ Time Frame: May 2012 ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: May 2012 ] [ Designated as safety issue: No ]
  • Disease free survival [ Time Frame: May 2012 ] [ Designated as safety issue: No ]
  • Late toxicity [ Time Frame: May 2012 ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: May 2009
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Tarceva
Tarceva 150 mg/day
Radiation: Radiotherapy
66 Gy/33 F/5 F per week for 5 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00888511

Locations
Denmark
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
Investigators
Principal Investigator: Olfred Hansen, MD Odense University Hospital
  More Information

Responsible Party: Olfred Hansen, MD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT00888511     History of Changes
Other Study ID Numbers: 09.02 
Study First Received: April 24, 2009
Last Updated: May 19, 2016
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee

Keywords provided by Odense University Hospital:
Lung cancer
Non-small cell lung cancer
Tarceva
Radiotherapy
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
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 25, 2016