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

Primary Purpose

Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Tarceva
Radiotherapy
Sponsored by
Olfred Hansen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Lung cancer, Non-small cell lung cancer, Tarceva, Radiotherapy, Local-regionally advanced non-small cell lung cancer

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Oncology, Aarhus University Hospital
  • Department of Oncology, Rigshospitalet
  • Department of Oncology, Copenhagen University Hospital at Herlev
  • Department of Oncology, Naestved Hospital
  • Laboratory of Radiation Physics
  • Odense University Hospital
  • Department of Oncology, Vejle Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Progression Free Survival
Progression free survival from registration according to RECIST 1.1

Secondary Outcome Measures

Toxicity
Local Tumor Control by CT-scan
Overall Response Rate (CR + PR)
Local Tumor Control at 9 Months Evaluated by PET-CT
Overall Survival
Disease Free Survival
Late Toxicity

Full Information

First Posted
April 24, 2009
Last Updated
November 4, 2020
Sponsor
Olfred Hansen
Collaborators
Odense University Hospital, Copenhagen University Hospital at Herlev, Rigshospitalet, Denmark, Aalborg University Hospital, Aarhus University Hospital, Naestved Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00888511
Brief Title
Tarceva And Radiotherapy in Locally Advanced Lung Cancer Non-small Cell Lung Cancer
Acronym
TARLAL
Official Title
Concomitant Tarceva® and Irradiation in Patients in Local-regionally Advanced Non-small Cell Lung Cancer. A Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Olfred Hansen
Collaborators
Odense University Hospital, Copenhagen University Hospital at Herlev, Rigshospitalet, Denmark, Aalborg University Hospital, Aarhus University Hospital, Naestved Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Lung cancer, Non-small cell lung cancer, Tarceva, Radiotherapy, Local-regionally advanced non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tarceva
Intervention Description
Tarceva 150 mg/day
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
66 Gy/33 F/5 F per week for 5 weeks
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
Progression free survival from registration according to RECIST 1.1
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Toxicity
Time Frame
3 years
Title
Local Tumor Control by CT-scan
Time Frame
May 2012
Title
Overall Response Rate (CR + PR)
Time Frame
May 2012
Title
Local Tumor Control at 9 Months Evaluated by PET-CT
Time Frame
May 2012
Title
Overall Survival
Time Frame
May 2012
Title
Disease Free Survival
Time Frame
May 2012
Title
Late Toxicity
Time Frame
May 2012

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olfred Hansen, MD
Organizational Affiliation
Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oncology, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Department of Oncology, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Department of Oncology, Copenhagen University Hospital at Herlev
City
Herlev
ZIP/Postal Code
270
Country
Denmark
Facility Name
Department of Oncology, Naestved Hospital
City
Naestved
Country
Denmark
Facility Name
Laboratory of Radiation Physics
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Department of Oncology, Vejle Hospital
City
Vejle
ZIP/Postal Code
7100
Country
Denmark

12. IPD Sharing Statement

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

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