Non-small-cell Lung Cancer Clinical Trial
— GECP-SCATOfficial 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
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 |
Randomized Study of Customized Adjuvant Chemotherapy based on BRCA1 mRNA Levels in Completely Resected stages II-IIIA Non-Small-Cell Lung Cancer Patients.
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Spanish Lung Cancer Group |
Spain,
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 |
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