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
  Purpose

Randomized Study of Customized Adjuvant Chemotherapy based on BRCA1 mRNA Levels in Completely Resected stages II-IIIA Non-Small-Cell Lung Cancer Patients.


Condition Intervention Phase
Non-small-cell Lung Cancer
Drug: Docetaxel/Cisplatin
Drug: Docetaxel
Drug: Gemcitabine/Cisplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Spanish Lung Cancer Group:

Primary Outcome Measures:
  • Evaluate overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 432
Study Start Date: June 2007
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Docetaxel/Cisplatin
Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles
Experimental: 2 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
Drug: Docetaxel/Cisplatin
Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478699

Contacts
Contact: Eva Pereira +34 93 430 20 06 epereira@gecp.org

  Show 51 Study Locations
Sponsors and Collaborators
Spanish Lung Cancer Group
Investigators
Study Chair: Bartomeu Massutí Sureda, MD HOSPITAL GENERAL UNIVERSITARIO DE ALICANTE
Study Chair: Jose Miguel Sanchez Torres, MD HOSPITAL DE LA PRINCESA
  More Information

Additional Information:
No publications provided

Responsible Party: Spanish Lung Cancer Group
ClinicalTrials.gov Identifier: NCT00478699     History of Changes
Other Study ID Numbers: GECP-SCAT, EudraCT Code: 2007-000067-15
Study First Received: May 24, 2007
Last Updated: December 13, 2012
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Spanish Lung Cancer Group:
SCAT
BRCA1
BRCA1 mRNA Levels
ADJUVANT
LUNG
GECP-SCAT

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Cisplatin
Docetaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on September 18, 2014