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


Phase 2
18 Years
90 Years
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Local failure free survival at 9 months after start of radiotherapy evaluated at CT scan

Outcome Time Frame:

May 2012

Safety Issue:

No

Principal Investigator

Olfred Hansen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Odense University Hospital

Authority:

Denmark: Danish Dataprotection Agency

Study ID:

09.02

NCT ID:

NCT00888511

Start Date:

May 2009

Completion Date:

April 2012

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Lung cancer
  • Non-small cell lung cancer
  • Tarceva
  • Radiotherapy
  • Local-regionally advanced non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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