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Phase III, Open, Multicenter and Randomized Study of Customized Adjuvant Chemotherapy Based on BRCA1 mRNA Levels in Completely Resected Stages II-IIIA Non-Small-Cell Lung Cancer Patients


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Non-small-cell Lung Cancer

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Trial Information

Phase III, Open, Multicenter and Randomized Study of Customized Adjuvant Chemotherapy Based on BRCA1 mRNA Levels in Completely Resected Stages II-IIIA Non-Small-Cell Lung Cancer Patients


Randomized, phase III, predictive pharmacogenomic, open, prospective, international,
multicenter study in patients with non-small-cell lung carcinoma (NSCLC) after complete
resection and with N1 or N2 involvement


Inclusion Criteria:



- Patients with histological confirmation of non-small-cell lung carcinoma.

- Complete surgical resection of the disease.

- Tumoral tissue available for molecular analysis.

- N1 (stage II) or N2 (stage IIIA) lymph node involvement in the study of the operative
piece.

- Men or women age 18 years or older.

- Patients with a performance status of 2 or less according to the ECOG classification.

- Patients with the following laboratory results: ANC < 1500/L, Hb < 10 g/dL, platelets
<100,000/L, bilirubin < 1.0 mg/dL, AST and ALT < 1.5 upper limit of normality,
creatinine clearance < 60 mL/min.

- Complete recovery from surgery within 6 weeks.

- Patients who have given written informed consent before initiating any specific study
screening procedure.

Exclusion Criteria:

- Patients who have received previously chemotherapy or radiotherapy for the study
disease.

- Impossibility of complying with chemotherapy treatment due to cultural or geographic
circumstances.

- Patients with active infection, heart disease, or any other serious disease, in the
judgment of the investigator.

- Women who are pregnant or in the period of lactation.

- Patients with a previous diagnosis of malignant disease in the last five years except
for carcinoma in situ of the uterine cervix or skin cancer other than melanoma.

- Patients under treatment with investigational agents.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate overall survival

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Bartomeu Massutí Sureda, MD

Investigator Role:

Study Chair

Investigator Affiliation:

HOSPITAL GENERAL UNIVERSITARIO DE ALICANTE

Authority:

Spain: Spanish Agency of Medicines

Study ID:

GECP-SCAT

NCT ID:

NCT00478699

Start Date:

June 2007

Completion Date:

December 2012

Related Keywords:

  • Non-Small-Cell Lung Cancer
  • SCAT
  • BRCA1
  • BRCA1 mRNA Levels
  • ADJUVANT
  • LUNG
  • GECP-SCAT
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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