Randomized Customized Adjuvant Chemotherapy (GECP-SCAT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Spanish Lung Cancer Group.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Spanish Lung Cancer Group
ClinicalTrials.gov Identifier:
NCT00478699
First received: May 24, 2007
Last updated: December 13, 2012
Last verified: March 2012

May 24, 2007
December 13, 2012
June 2007
December 2012   (final data collection date for primary outcome measure)
Evaluate overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Evaluate overall survival
Complete list of historical versions of study NCT00478699 on ClinicalTrials.gov Archive Site
Evaluate the disease-free survival, pattern of recurrences, toxicity profile and potential genetic markers of response and/or resistance to treatment. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Evaluate the disease-free survival, pattern of recurrences, toxicity profile and potential genetic markers of response and/or resistance to treatment.
Not Provided
Not Provided
 
Randomized Customized Adjuvant Chemotherapy (GECP-SCAT)
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 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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-small-cell Lung Cancer
  • Drug: Docetaxel/Cisplatin
    Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles
  • Drug: Docetaxel
    Docetaxel 75 mg/m2 day 1, 4 cycles
  • Drug: Gemcitabine/Cisplatin
    Gemcitabine 1250 mg/m2, day 1 and 8 and cisplatin 75 mg/m2 day 1, 4 cycles
  • Active Comparator: 1
    Intervention: Drug: Docetaxel/Cisplatin
  • Experimental: 2
    Interventions:
    • Drug: Docetaxel
    • Drug: Gemcitabine/Cisplatin
    • Drug: Docetaxel/Cisplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
432
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Eva Pereira +34 93 430 20 06 epereira@gecp.org
Spain
 
NCT00478699
GECP-SCAT, EudraCT Code: 2007-000067-15
Yes
Spanish Lung Cancer Group
Spanish Lung Cancer Group
Not Provided
Study Chair: Bartomeu Massutí Sureda, MD HOSPITAL GENERAL UNIVERSITARIO DE ALICANTE
Study Chair: Jose Miguel Sanchez Torres, MD HOSPITAL DE LA PRINCESA
Spanish Lung Cancer Group
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP