Randomized Customized Adjuvant Chemotherapy (GECP-SCAT)

Non-small-cell Lung Cancer Clinical Trial

— GECP-SCAT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00478699
• Other study ID #: GECP-SCAT
• Secondary ID: EudraCT Code: 20
• Status: Completed
• Phase: Phase 3
• First received: May 24, 2007
• Last updated: July 3, 2015
• Start date: June 2007
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: Spanish Lung Cancer Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small-cell Lung Cancer

Intervention

Drug:
• Docetaxel/Cisplatin
Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles
• Docetaxel
Docetaxel 75 mg/m2 day 1, 4 cycles
• Gemcitabine/Cisplatin
Gemcitabine 1250 mg/m2, day 1 and 8 and cisplatin 75 mg/m2 day 1, 4 cycles
• Docetaxel/Cisplatin
Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles

Locations

Country	Name	City	State
Spain	F.H.Alcorcon	Alcorcon	Madrid
Spain	H.G.U. Alicante	Alicante
Spain	Hospital de La Ribera	Alzira	Valencia
Spain	Ico - H. Germans Trias I Pujol	Badalona	Barcelona
Spain	Hospital de Cruces	Baracaldo	Vizcaya
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital de La Santa Creu I Sant Pau	Barcelona
Spain	Hospital Univ. Sagrat Cor	Barcelona
Spain	Instituto Universitario Dexeus	Barcelona
Spain	Hospital de Basurto	Bilbao	Vizcaya
Spain	Hospital Provincial de Castellón	Castellón
Spain	Hospital Reina Sofía	Córdoba
Spain	Hospital de Elche	Elche	Alicante
Spain	Ico-Girona (Hospital Josep Trueta)	Girona
Spain	Hospital Virgen de Las Nieves	Granada
Spain	Hospital de Jaén	Jaén
Spain	Hospital Insular de Gran Canaria	Las Palmas de Gran Canaria	Gran Canaria
Spain	Hospital Severo Ochoa	Leganés	Madrid
Spain	Hospital de León	Leon
Spain	Hospital Arnau de Vilanova	Lleida
Spain	Hospital San Pedro	Logrono	La Rioja
Spain	Fundación Jiménez Díaz	Madrid
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital de La Princesa	Madrid
Spain	Hospital La Paz	Madrid
Spain	Hospital Puerta de Hierro	Madrid
Spain	Md Anderson Internacional	Madrid
Spain	Hospital Carlos Haya	Malaga
Spain	Hospital D'Althaia	Manresa	Barcelona
Spain	Hospital de Mataró	Mataró	Barcelona
Spain	Hospital Morales Messeguer	Murcia
Spain	Hospital Central de Asturias	Oviedo	Asturias
Spain	Clínica Rotger	Palma de Mallorca
Spain	Hospital Son Dureta	Palma de Mallorca
Spain	Hospital Son Llátzer	Palma de Mallorca
Spain	Hospital Clinico de Salamanca	Salamanca
Spain	Hospital de Donostia	San Sebastián
Spain	Instituto Oncológico de San Sebastián	San Sebastián
Spain	Hospital Universitario de Canarias	Santa Cruz de Tenerife
Spain	Hospital Clin. Univ. Santiago de Compostela	Santiago de Compostela	La Coruna
Spain	H. Arnau de Vilanova	Valencia
Spain	Hospital General de Valencia	Valencia
Spain	Instituto Valenciano de Oncología	Valencia
Spain	Hospital Provincial de Zamora	Zamora
Spain	Hospital Lozano Blesa	Zaragoza
Spain	Hospital Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Spanish Lung Cancer Group

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate overall survival		5 years	No
Secondary	Evaluate the disease-free survival, pattern of recurrences, toxicity profile and potential genetic markers of response and/or resistance to treatment.		5 years	Yes

External Links

•   Spanish Lung Cancer Group website