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Phase II Randomized Trial of 3D Radiotherapy Versus the Combination of 3D Radiotherapy and Erlotinib (Tarceva®) in Patients With Localized-Unresectable Non-Small Cell Lung Cancer Non Susceptible for Chemotherapy Treatment.


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Non-Small-Cell Lung

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Trial Information

Phase II Randomized Trial of 3D Radiotherapy Versus the Combination of 3D Radiotherapy and Erlotinib (Tarceva®) in Patients With Localized-Unresectable Non-Small Cell Lung Cancer Non Susceptible for Chemotherapy Treatment.


Inclusion Criteria:



- Written informed consent prior to any specific procedure of the protocol.

- Histologically confirmed diagnosis of non small cell lung cancer.

- Unresectable (IA-IIIB) non-small cell lung cancer.

- Patients non susceptible for chemotherapy treatment

- Measurable disease according to RECIST criteria

- Age > 18 years.

- ECOG performance status < 2.

- Adequate bone marrow, hepatic, renal and respiratory function.

- Patients capable of following an adequate therapeutic compliance and accessible for a
correct follow-up.

- Women at a fertile age must have a negative serum or urine pregnancy test within the
7 days prior to the beginning of the treatment.

- Patients of both genders at a fertile age, including those women having their last
menstruation within the two previous years, must follow effective contraceptive
measures.

Exclusion Criteria:

- Prior chemotherapy or radiotherapy.

- History of other curatively treated malignancy and no evidence of disease within the
past 5 years except squamous cell skin cancer, or resected cervix carcinoma.

- Pregnant or lactating women.

- Any other severe disease or clinical conditions, as, but not only:

1. Unstable cardiopathy despite treatment, myocardial infarction within the 6
months before entering the study

2. Uncontrolled active infection

3. Uncontrolled peptic ulcer, unstable diabetes mellitus or any other
contraindication for treatment with corticosteroids.

4. Autoimmune diseases.

- Concomitant treatment with any other antineoplastic therapy.

- Prior experimental pharmacological agent within the 3 weeks prior to the inclusion of
the study.

- Prior treatment with EGFR targeted therapies.

- Erlotinib known hypersensibility.

- Any radiotherapy treatment contraindication.

- History of significant neurological or psychiatric disorders, including epileptic
seizures.

- Any significant ophthalmologic impairment of the eye surface (Use of contact lenses
is not recommended)

- Inability to take oral medication and surgical procedures affecting the absorption or
implying intravenous or parenteral feeding.

- Any other underlying severe process affecting the ability to take part in the study.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determinate the viability and toxicity profile of Erlotinib + 3D Radiotherapy treatment (% of patients presenting toxicity 3-4 during the treatment).

Principal Investigator

Enrique Martínez, Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital de Navarra

Authority:

Spain: Spanish Agency of Medicines

Study ID:

MO19182

NCT ID:

NCT00466089

Start Date:

March 2006

Completion Date:

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • NSCLC, lung cancer
  • Patients with localized-unresectable (IA-IIIB) non-small cell lung cancer non susceptible for chemotherapy treatment.
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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