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Completed

NCT Number: NCT00478699

Randomized Customized Adjuvant Chemotherapy (GECP-SCAT)

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

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Key information

Conditions

Non-Small-Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital de Elche, Elche, Alicante, Spain

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Docetaxel/Cisplatin control

Drug

Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles

Other names: Taxotere/Platinol

docetaxel

Drug

Docetaxel 75 mg/m2 day 1, 4 cycles

Other names: Taxotere

Gemcitabine/Cisplatin

Drug

Gemcitabine 1250 mg/m2, day 1 and 8 and cisplatin 75 mg/m2 day 1, 4 cycles

Other names: Gemzar/Platinol

Docetaxel/cisplatin

Drug

Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles

Other names: Taxotere/Platinol

Primary outcomes

  1. Estimated Overall Survival

    Time frame: 5 years

    To assess and compare the overall survival estimated at 5 years of both treatment groups (Control arm vs Experimental arm).

    Overall survival:The proportion of participants in treatment group who are still alive for a certain period of time after inclusion.

Secondary outcomes

  1. Disease Free Survival

    Time frame: 5 years

    To assess the disease-free survival of both treatment groups. Disease-free survival: will be calculated from the date of surgery until there is some clinical evidence of disease progression or the date of death due to the disease.

Sponsors and collaborators

Lead sponsor

Spanish Lung Cancer Group

Other

Registry information

Official study 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

Acronym: GECP-SCAT

Important dates

Study start
2007
Primary completion
2015
Study completion
2015
First posted
May 25, 2007
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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