Clinical trial NCT00478699: Randomized Customized Adjuvant Chemotherapy (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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-small-cell Lung Cancer
Keywords: SCAT
BRCA1
BRCA1 mRNA Levels
ADJUVANT
LUNG
GECP-SCAT
Lead sponsor: Spanish Lung Cancer Group
Sponsor class: OTHER
First posted: 2007-05-25
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Estimated Overall Survival
timeFrame: 5 years
Secondary outcomes:
measure: Disease Free Survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Hospital de Elche
state: Alicante
city: Oviedo
country: Spain
facility: Hospital Central de Asturias
state: Asturias
city: Badalona
country: Spain
facility: Ico - H. Germans Trias I Pujol
state: Barcelona
city: Manresa
country: Spain
facility: Hospital D'Althaia
state: Barcelona
city: Mataró
country: Spain
facility: Hospital de Mataró
state: Barcelona
city: Castellón De La Plana
country: Spain
facility: Hospital Provincial de Castellón
state: Castellón
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Insular de Gran Canaria
state: GRAN Canaria
city: Santiago de Compostela
country: Spain
facility: Hospital Clin. Univ. Santiago de Compostela
state: LA Coruna
city: Logrono
country: Spain
facility: Hospital San Pedro
state: LA Rioja
city: Alcorcon
country: Spain
facility: F.H.Alcorcon
state: Madrid
city: Leganés
country: Spain
facility: Hospital Severo Ochoa
state: Madrid
city: Alzira
country: Spain
facility: Hospital de La Ribera
state: Valencia
city: Baracaldo
country: Spain
facility: Hospital de Cruces
state: Vizcaya
city: Bilbao
country: Spain
facility: Hospital de Basurto
state: Vizcaya
city: Alicante
country: Spain
facility: H.G.U. Alicante
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu I Sant Pau
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Univ. Sagrat Cor
city: Barcelona
country: Spain
facility: Instituto Universitario Dexeus
city: Córdoba
country: Spain
facility: Hospital Reina Sofía
city: Girona
country: Spain
facility: Ico-Girona (Hospital Josep Trueta)
city: Granada
country: Spain
facility: Hospital Virgen de Las Nieves
city: Jaén
country: Spain
facility: Hospital de Jaén
city: Leon
country: Spain
facility: Hospital de León
city: Lleida
country: Spain
facility: Hospital Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital de La Princesa
city: Madrid
country: Spain
facility: Md Anderson Internacional
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital La Paz
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro
city: Malaga
country: Spain
facility: Hospital Carlos Haya
city: Murcia
country: Spain
facility: Hospital Morales Messeguer
city: Palma de Mallorca
country: Spain
facility: Clínica Rotger
city: Palma de Mallorca
country: Spain
facility: Hospital Son Dureta
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llátzer
city: Salamanca
country: Spain
facility: Hospital Clinico de Salamanca
city: San Sebastián
country: Spain
facility: Hospital de Donostia
city: San Sebastián
country: Spain
facility: Instituto Oncológico de San Sebastián
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario de Canarias
city: Valencia
country: Spain
facility: H. Arnau de Vilanova
city: Valencia
country: Spain
facility: Hospital General de Valencia
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncología
city: Zamora
country: Spain
facility: Hospital Provincial de Zamora
city: Zaragoza
country: Spain
facility: Hospital Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
affiliation: Hospital General Universitario de Alicante
name: Bartomeu Massutí Sureda, MD
role: STUDY_CHAIR
affiliation: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
name: Jose Miguel Sanchez Torres, MD
role: STUDY_CHAIR
References: