Study to Evaluate Treatment Customized According to RAP80 and BRCA1 in Patients With Advanced Lung Carcinoma
- Conditions
- BRCA1 MutationNon Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT00617656
- Lead Sponsor
- Spanish Lung Cancer Group
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 382
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A: Control Cisplatin, Docetaxel Docetaxel 75 mg/m2 and cisplatin 75 mg/m2, both on day 1, every 21 days. Total number of cycles: 6 B1: Experimental group B1 Gemcitabine, Cisplatin Low RAP expression and any levels of BRCA1 expression: Gemcitabine 1250 mg/m2, days 1 and 8, and Cisplatin 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6 B2: Experimental group B2 Docetaxel, Cisplatin Intermediate or high RAP expression and low or intermediate BRCA1 expression: Docetaxel 75 mg/m2 and Cisplatin 75 mg/m2, both administered on day 1, every 21 days. Total number of cycles: 6 B3: Experimental group B3 Docetaxel Intermediate or high RAP expression and high BRCA1 expression: Docetaxel 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6
- Primary Outcome Measures
Name Time Method Progression Free Survival From the day of start of treatment until first documented progression or death due to any cause,up to 18 months. Defined as the length of time from the start of treatment to the date of the first documented progression of disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
- Secondary Outcome Measures
Name Time Method Overall Survival From the date of start of the treatment until death or end of follow up, up to 18 months. Defined as the length of time from the start of the treatment that patients diagnosed with the disease are still alive.
Trial Locations
- Locations (44)
H. Gen. Univ. Valencia
🇪🇸Valencia, Spain
H. General de Vic
🇪🇸Vic, Spain
Hospital de La Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
Fundación Jiménez Díaz
🇪🇸Madrid, Spain
H. Santiago de Compostela
🇪🇸A Coruña, Spain
Clinica Quiron
🇪🇸Pozuelo De Alarcón, Madrid, Spain
F.H.Alcorcón
🇪🇸Alcorcon, Madrid, Spain
Hospital Universitario Quirón Madrid
🇪🇸Pozuelo De Alarcón, Madrid, Spain
Hospital de Basurto
🇪🇸Bilbao, Vizcaya, Spain
H. Gral. Alicante
🇪🇸Alicante, Spain
H. Severo Ochoa
🇪🇸Leganés, Madrid, Spain
Hospital D'Althaia
🇪🇸Manresa, Barcelona, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital de Mataró
🇪🇸Mataró, Barcelona, Spain
H. Torrecárdenas
🇪🇸Almería, Spain
H. Clinic i Provincial
🇪🇸Barcelona, Spain
H. Universitario Quirón Dexeus
🇪🇸Barcelona, Spain
Hospital Gregorio Marañon
🇪🇸Madrid, Spain
Hospital Universitari de Girona Dr. Josep Trueta
🇪🇸Girona, Spain
Hospital Virgen de las Nieves
🇪🇸Granada, Spain
Hospital Carlos Haya
🇪🇸Málaga, Spain
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Hospital nuestra señora de Valme
🇪🇸Sevilla, Spain
Hospital Arnau de Vilanova
🇪🇸Valencia, Spain
Hospital Son Dureta/ Ses Espases
🇪🇸Palma De Mallorca, Spain
H. Virgen de los Lirios
🇪🇸Alcoi, Alicante, Spain
H. Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Hospital Ernest Lluch
🇪🇸Calatayud, Zaragoza, Spain
H. Juan Canalejo
🇪🇸A Coruña, Spain
Hospital Morales Messeguer
🇪🇸Murcia, Spain
Hospital de Cruces
🇪🇸Barakaldo, Bizkaia, Spain
Hospital Reina Sofía
🇪🇸Cordoba, Córdoba, Spain
H. Duran i Reynals-ICO
🇪🇸Barcelona, Spain
H. Provincial de Castellón
🇪🇸Castelló, Spain
Hospital Torrecárdenas
🇪🇸Almería, Spain
Hospital Ciudad de Jaén
🇪🇸Jaén, Spain
Hospital General Yagüe
🇪🇸Burgos, Spain
H.U. Puerta de Hierro
🇪🇸Madrid, Spain
H. de la Princesa
🇪🇸Madrid, Spain
H. Son Llátzer
🇪🇸Palma De Mallorca, Spain
Hospital Virgen de la Victoria
🇪🇸Málaga, Spain
Hospital Clínico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Clínico Lozano Blesa
🇪🇸Zaragoza, Spain
H. Clínico Lozano Blesa
🇪🇸Zaragoza, Spain