Randomized Customized Adjuvant Chemotherapy (GECP-SCAT)
NCT ID: NCT00478699
Last Updated: 2024-12-12
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
500 participants
INTERVENTIONAL
2007-06-30
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1 Control group
Control group:
\*Docetaxel 75 mg/m2, and cisplatin 75 mg/m2, both on day 1, every 21 days. Total cycles: Four.
Docetaxel/Cisplatin control
Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles
2 Experimental group
Experimental group, according to the BRAC1 levels of the tumor tissue, will be assigned one of the following treatments:
* Low expression of BRCA1 → gemcitabine 1250 mg/m2, days 1 and 8, and cisplatin 75 mg/m2, day 1. Cycles every 21 days. Total cycles: 4
* Intermediate expression levels of BRCA1 → docetaxel 75 mg/m2, and cisplatin 75 mg/m2, both administered on day 1, every 21 days. Total cycles: 4.
* High expression levels of BRCA1 → docetaxel 75 mg/m2, day 1. Cycles every 21 days. Total cycles: 4.
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
Interventions
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Docetaxel/Cisplatin control
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Spanish Lung Cancer Group
OTHER
Responsible Party
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Principal Investigators
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Bartomeu Massutí Sureda, MD
Role: STUDY_CHAIR
Hospital General Universitario de Alicante
Jose Miguel Sanchez Torres, MD
Role: STUDY_CHAIR
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Locations
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Hospital de Elche
Elche, Alicante, Spain
Ico - H. Germans Trias I Pujol
Badalona, Barcelona, Spain
Hospital D'Althaia
Manresa, Barcelona, Spain
Hospital de Mataró
Mataró, Barcelona, Spain
Hospital Provincial de Castellón
Castellon, Castellón, Spain
Hospital Insular de Gran Canaria
Las Palmas de Gran Canaria, GRAN Canaria, Spain
Hospital Clin. Univ. Santiago de Compostela
Santiago de Compostela, LA Coruna, Spain
Hospital San Pedro
Logroño, La Rioja, Spain
F.H.Alcorcon
Alcorcón, Madrid, Spain
Hospital Severo Ochoa
Leganés, Madrid, Spain
Hospital Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital de La Ribera
Alzira, Valencia, Spain
Hospital de Cruces
Barakaldo, Vizcaya, Spain
Hospital de Basurto
Bilbao, Vizcaya, Spain
H.G.U. Alicante
Alicante, , Spain
Hospital de La Santa Creu I Sant Pau
Barcelona, , Spain
Hospital Clínic de Barcelona
Barcelona, , Spain
Hospital Univ. Sagrat Cor
Barcelona, , Spain
Instituto Universitario Dexeus
Barcelona, , Spain
Hospital Reina Sofía
Córdoba, , Spain
Ico-Girona (Hospital Josep Trueta)
Girona, , Spain
Hospital Virgen de Las Nieves
Granada, , Spain
Hospital de Jaén
Jaén, , Spain
Hospital de León
León, , Spain
Hospital Arnau de Vilanova
Lleida, , Spain
Hospital 12 de Octubre
Madrid, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital de La Princesa
Madrid, , Spain
Md Anderson Internacional
Madrid, , Spain
Fundación Jiménez Díaz
Madrid, , Spain
Hospital La Paz
Madrid, , Spain
Hospital Puerta de Hierro
Madrid, , Spain
Hospital Carlos Haya
Málaga, , Spain
Hospital Morales Messeguer
Murcia, , 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
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, , Spain
Countries
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Related Links
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Spanish Lung Cancer Group website
Other Identifiers
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2007-000067-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GECP-SCAT
Identifier Type: -
Identifier Source: org_study_id