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Spots Global Cancer Trial Database for Study to Evaluate Treatment Customized According to RAP80 and BRCA1 in Patients With Advanced Lung Carcinoma

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Trial Identification

Brief Title: Study to Evaluate Treatment Customized According to RAP80 and BRCA1 in Patients With Advanced Lung Carcinoma

Official Title: Multicenter Phase III, Randomized Study to Evaluate Treatment Customized According to RAP80 and BRCA1 Assessment in Patients With Advanced Non-small-cell Lung Cancer

Study ID: NCT00617656

Study Description

Brief Summary: Primary objective: · Progression free survival. Secondary objectives: * Assess Overall survival of both treatment groups. * Assess Tumor response rate using RECIST criteria * Assess Toxicity profile of patients enrolled in the study. * Exploratory evaluation of potential genetic markers of response or resistance to chemotherapy.

Detailed Description: Study population: Patients with advanced non-small-cell lung cancer who have not received treatment for the disease at this stage and who have a good performance status (ECOG 0-1) and measurable disease (at least one target lesion according to RECIST criteria). Duration of treatment: Six chemotherapy cycles will be given. The duration of every cycle will be 21 days. If the treatment is beneficial, it may be prolonged to a total of 8 cycles at the discretion of the investigator. Calendar and planned finalization date: The approximate duration of the study is 3 years of recruitment followed by 1 year of follow-up.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

H. Virgen de los Lirios, Alcoi, Alicante, Spain

H. Germans Trias i Pujol, Badalona, Barcelona, Spain

Hospital D'Althaia, Manresa, Barcelona, Spain

Hospital de Mataró, Mataró, Barcelona, Spain

Hospital de Cruces, Barakaldo, Bizkaia, Spain

Hospital Reina Sofía, Cordoba, Córdoba, Spain

F.H.Alcorcón, Alcorcon, Madrid, Spain

H. Severo Ochoa, Leganés, Madrid, Spain

Clinica Quiron, Pozuelo De Alarcón, Madrid, Spain

Hospital Universitario Quirón Madrid, Pozuelo De Alarcón, Madrid, Spain

Hospital de Basurto, Bilbao, Vizcaya, Spain

Hospital Ernest Lluch, Calatayud, Zaragoza, Spain

H. Juan Canalejo, A Coruña, , Spain

H. Santiago de Compostela, A Coruña, , Spain

H. Gral. Alicante, Alicante, , Spain

H. Torrecárdenas, Almería, , Spain

Hospital Torrecárdenas, Almería, , Spain

H. Clinic i Provincial, Barcelona, , Spain

H. Universitario Quirón Dexeus, Barcelona, , Spain

Hospital de La Santa Creu I Sant Pau, Barcelona, , Spain

H. Duran i Reynals-ICO, Barcelona, , Spain

Hospital del Mar, Barcelona, , Spain

Hospital General Yagüe, Burgos, , Spain

H. Provincial de Castellón, Castelló, , Spain

Hospital Universitari de Girona Dr. Josep Trueta, Girona, , Spain

Hospital Virgen de las Nieves, Granada, , Spain

Hospital Ciudad de Jaén, Jaén, , Spain

H. de la Princesa, Madrid, , Spain

H.U. Puerta de Hierro, Madrid, , Spain

Fundación Jiménez Díaz, Madrid, , Spain

Hospital Clínico San Carlos, Madrid, , Spain

Hospital Gregorio Marañon, Madrid, , Spain

Hospital Morales Messeguer, Murcia, , Spain

Hospital Carlos Haya, Málaga, , Spain

Hospital Virgen de la Victoria, Málaga, , Spain

Hospital Son Dureta/ Ses Espases, Palma De Mallorca, , Spain

H. Son Llátzer, Palma De Mallorca, , Spain

Hospital nuestra señora de Valme, Sevilla, , Spain

Hospital Clínico Universitario de Valencia, Valencia, , Spain

H. Gen. Univ. Valencia, Valencia, , Spain

Hospital Arnau de Vilanova, Valencia, , Spain

H. General de Vic, Vic, , Spain

Hospital Clínico Lozano Blesa, Zaragoza, , Spain

H. Clínico Lozano Blesa, Zaragoza, , Spain

Contact Details

Name: Rafel Rossell, MD

Affiliation: Principal Investigator of Fundación Grupo Español de Cáncer de Pulmón

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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