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
Recruitment status was Recruiting
Sponsor:
Odense University Hospital
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
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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
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 May 21, 2013