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NCT Number: NCT00888511

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

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).

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Oncology, Aarhus University Hospital, Aarhus, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tarceva

Drug

Tarceva 150 mg/day

Radiotherapy

Radiation

66 Gy/33 F/5 F per week for 5 weeks

Primary outcomes

  1. Progression Free Survival

    Time frame: 3 years

    Progression free survival from registration according to RECIST 1.1

Secondary outcomes

  1. Toxicity

    Time frame: 3 years

  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

Sponsors and collaborators

Lead sponsor

Olfred Hansen

Other

Collaborators

  • Aalborg University Hospital
  • Aarhus University Hospital
  • Copenhagen University Hospital at Herlev
  • Naestved Hospital
  • Odense University Hospital
  • Rigshospitalet, Denmark

Registry information

Official study title

Concomitant Tarceva® and Irradiation in Patients in Local-regionally Advanced Non-small Cell Lung Cancer. A Phase II Study

Acronym: TARLAL

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Apr 27, 2009
Registry last updated
Nov 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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