Randomized Customized Adjuvant Chemotherapy (GECP-SCAT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Spanish Lung Cancer Group
ClinicalTrials.gov Identifier:
NCT00478699
First received: May 24, 2007
Last updated: July 3, 2015
Last verified: July 2015
  Purpose

Randomized Study of Customized Adjuvant Chemotherapy based on BRCA1 mRNA Levels in Completely Resected stages II-IIIA Non-Small-Cell Lung Cancer Patients.


Condition Intervention Phase
Non-small-cell Lung Cancer
Drug: Docetaxel/Cisplatin
Drug: Docetaxel
Drug: Gemcitabine/Cisplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Spanish Lung Cancer Group:

Primary Outcome Measures:
  • Evaluate overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the disease-free survival, pattern of recurrences, toxicity profile and potential genetic markers of response and/or resistance to treatment. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 500
Study Start Date: June 2007
Study Completion Date: July 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Docetaxel/Cisplatin
Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles
Experimental: 2 Drug: Docetaxel
Docetaxel 75 mg/m2 day 1, 4 cycles
Drug: Gemcitabine/Cisplatin
Gemcitabine 1250 mg/m2, day 1 and 8 and cisplatin 75 mg/m2 day 1, 4 cycles
Drug: Docetaxel/Cisplatin
Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478699

Locations
Spain
Hospital de Elche
Elche, Alicante, Spain, 03202
Hospital Central de Asturias
Oviedo, Asturias, Spain
Ico - H. Germans Trias I Pujol
Badalona, Barcelona, Spain, 08916
Hospital D'Althaia
Manresa, Barcelona, Spain, 08243
Hospital de Mataró
Mataró, Barcelona, Spain, 08034
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, 15076
Hospital San Pedro
Logrono, La Rioja, Spain, 26004
F.H.Alcorcon
Alcorcon, Madrid, Spain, 28922
Hospital Severo Ochoa
Leganés, Madrid, Spain, 28911
Hospital de La Ribera
Alzira, Valencia, Spain, 46600
Hospital de Cruces
Baracaldo, Vizcaya, Spain, 48903
Hospital de Basurto
Bilbao, Vizcaya, Spain
H.G.U. Alicante
Alicante, Spain, 03010
Hospital Univ. Sagrat Cor
Barcelona, Spain, 08036
Hospital de La Santa Creu I Sant Pau
Barcelona, Spain, 08025
Hospital Clínic de Barcelona
Barcelona, Spain, 08036
Instituto Universitario Dexeus
Barcelona, Spain, 28036
Hospital Provincial de Castellón
Castellón, Spain
Hospital Reina Sofía
Córdoba, Spain, 14004
Ico-Girona (Hospital Josep Trueta)
Girona, Spain, 17007
Hospital Virgen de Las Nieves
Granada, Spain, 18015
Hospital de Jaén
Jaén, Spain, 23007
Hospital de León
Leon, Spain
Hospital Arnau de Vilanova
Lleida, Spain, 46015
Fundación Jiménez Díaz
Madrid, Spain, 28040
Hospital 12 de Octubre
Madrid, Spain, 28006
Md Anderson Internacional
Madrid, Spain, 28033
Hospital de La Princesa
Madrid, Spain, 28006
Hospital La Paz
Madrid, Spain, 28046
Hospital Puerta de Hierro
Madrid, Spain, 28222
Hospital Clínico San Carlos
Madrid, Spain, 28006
Hospital Carlos Haya
Malaga, Spain, 29010
Hospital Morales Messeguer
Murcia, Spain, 30008
Clínica Rotger
Palma de Mallorca, Spain, 07012
Hospital Son Dureta
Palma de Mallorca, Spain, 07014
Hospital Son Llátzer
Palma de Mallorca, Spain, 07198
Hospital Clinico de Salamanca
Salamanca, Spain, 37007
Instituto Oncológico de San Sebastián
San Sebastián, Spain
Hospital de Donostia
San Sebastián, Spain, 20014
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Spain
Instituto Valenciano de Oncología
Valencia, Spain
Hospital General de Valencia
Valencia, Spain
H. Arnau de Vilanova
Valencia, Spain, 46015
Hospital Provincial de Zamora
Zamora, Spain, 49012
Hospital Lozano Blesa
Zaragoza, Spain
Hospital Miguel Servet
Zaragoza, Spain
Sponsors and Collaborators
Spanish Lung Cancer Group
Investigators
Study Chair: Bartomeu Massutí Sureda, MD HOSPITAL GENERAL UNIVERSITARIO DE ALICANTE
Study Chair: Jose Miguel Sanchez Torres, MD HOSPITAL DE LA PRINCESA
  More Information

Additional Information:
No publications provided

Responsible Party: Spanish Lung Cancer Group
ClinicalTrials.gov Identifier: NCT00478699     History of Changes
Other Study ID Numbers: GECP-SCAT, EudraCT Code: 2007-000067-15
Study First Received: May 24, 2007
Last Updated: July 3, 2015
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Spanish Lung Cancer Group:
SCAT
BRCA1
BRCA1 mRNA Levels
ADJUVANT
LUNG
GECP-SCAT

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Cisplatin
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on July 07, 2015