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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Odense University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Copenhagen University Hospital at Herlev
Rigshospitalet, Denmark
Aalborg Universityhospital
Aarhus University Hospital
Naestved Hospital
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00888511
First received: April 24, 2009
Last updated: November 12, 2009
Last verified: November 2009
  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: Allocation: Non-Randomized
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 ]

Estimated Enrollment: 57
Study Start Date: May 2009
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: May 2011 (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
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

Contacts
Contact: Olfred Hansen, MD +45 6541 1867 olfred.hansen@ouh.regionsyddanmark.dk

Locations
Denmark
Department of Oncology, Aarhus University Hospital Not yet recruiting
Aarhus, Denmark, 8000
Contact: Peter Melgaard, MD    +45 8949 2609    petemeld@rm.dk   
Contact: Marianne Knap, MD    +45 8949 2609    mariknap@rm.dk   
Principal Investigator: Peter Melgaard, MD         
Sub-Investigator: Marianne Knap, MD         
Department of Oncology, Rigshospitalet Not yet recruiting
Copenhagen, Denmark, 2100
Contact: Jens Benn Soernsen, Professor    +45 3545 3545    jens.benn.soerensen@rh.regionh.dk   
Contact: Jan Nyman, MD    +45 3545 3545    jan.nyman@rh.regionh.dk   
Principal Investigator: Jens Benn Soerensen, Professor         
Sub-Investigator: Jan Nyman, MD         
Department of Oncology, Copenhagen University Hospital at Herlev Not yet recruiting
Herlev, Denmark, 270
Contact: Bente Holm, MD       benhol01@regionh.dk   
Contact: Anders Mellemgaard, MD       andmel@heh.regionh.dk   
Principal Investigator: Bente Holm, MD         
Sub-Investigator: Anders Mellemgaard, MD         
Department of Oncology, Naestved Hospital Not yet recruiting
Naestved, Denmark
Contact: Kim Wederwang, MD       kwd@regionsjaelland.dk   
Principal Investigator: Kim Wedervang, MD         
Laboratory of Radiation Physics Not yet recruiting
Odense, Denmark, 5000
Contact: Carsten Brink, Physicist    +45 6541 2908    carsten.brink@ouh.regionsyddanmark.dk   
Principal Investigator: Carsten Brink, Physicist         
Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Olfred Hansen, MD    +45 6541 1867    olfred.hansen@ouh.regionsyddanmark.dk   
Contact: Merete Martin, Research Nurse    +45 6541 3238    merete.martin@ouh.regionsyddanmark.dk   
Principal Investigator: Olfred Hansen, MD         
Sub-Investigator: Tine Schytte, MD         
Department of Oncology, Vejle Hospital Not yet recruiting
Vejle, Denmark, 7100
Contact: Bente Soerensen, MD    +45 7940 5000    bente.thornfeldt.soerensen@slb.regionsyddanmark.dk   
Principal Investigator: Bente Soerensen, MD         
Sponsors and Collaborators
Odense University Hospital
Copenhagen University Hospital at Herlev
Rigshospitalet, Denmark
Aalborg Universityhospital
Aarhus University Hospital
Naestved Hospital
Investigators
Principal Investigator: Olfred Hansen, MD Odense University Hospital
  More Information

No publications provided

Responsible Party: Olfred Hansen, Odense University Hospital
ClinicalTrials.gov Identifier: NCT00888511     History of Changes
Other Study ID Numbers: 09.02
Study First Received: April 24, 2009
Last Updated: November 12, 2009
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:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014