Randomized Customized Adjuvant Chemotherapy (GECP-SCAT) (GECP-SCAT)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Spanish Lung Cancer Group

ClinicalTrials.gov Identifier:

NCT00478699

First received: May 24, 2007

Last updated: July 3, 2015

Last verified: July 2015

History of Changes

Tracking Information

First Received Date ^ICMJE

May 24, 2007

Last Updated Date

July 3, 2015

Start Date ^ICMJE

June 2007

Primary Completion Date

June 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Evaluate overall survival [ Time Frame: 5 years ]

Original Primary Outcome Measures ^ICMJE

Evaluate overall survival

Change History

Complete list of historical versions of study NCT00478699 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Evaluate the disease-free survival, pattern of recurrences, toxicity profile and potential genetic markers of response and/or resistance to treatment.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Randomized Customized Adjuvant Chemotherapy (GECP-SCAT)

Official Title ^ICMJE

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

Brief Summary

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

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Non-small-cell Lung Cancer

Intervention ^ICMJE

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

Study Arms

Active Comparator: 1
Intervention: Drug: Docetaxel/Cisplatin
Experimental: 2
Interventions:
- Drug: Docetaxel
- Drug: Gemcitabine/Cisplatin
- Drug: Docetaxel/Cisplatin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

500

Completion Date

July 2015

Primary Completion Date

June 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Spain

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00478699

Other Study ID Numbers ^ICMJE

GECP-SCAT
EudraCT Code: 2007-000067-15

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Spanish Lung Cancer Group

Study Sponsor ^ICMJE

Spanish Lung Cancer Group

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:	Bartomeu Massutí Sureda, MD	Hospital General Universitario de Alicante
Study Chair:	Jose Miguel Sanchez Torres, MD	HOSPITAL DE LA PRINCESA

PRS Account

Spanish Lung Cancer Group

Verification Date

July 2015

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

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