Randomized Customized Adjuvant Chemotherapy (GECP-SCAT)
GECP-SCAT
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
2 other identifiers
interventional
500
1 country
47
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2007
Longer than P75 for phase_3
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2007
CompletedFirst Posted
Study publicly available on registry
May 25, 2007
CompletedStudy Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedResults Posted
Study results publicly available
December 12, 2024
CompletedDecember 12, 2024
October 1, 2024
8 years
May 24, 2007
May 31, 2022
October 28, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Estimated Overall Survival
To assess and compare the overall survival estimated at 5 years of both treatment groups (Control arm vs Experimental arm). Overall survival:The proportion of participants in treatment group who are still alive for a certain period of time after inclusion.
5 years
Secondary Outcomes (1)
Disease Free Survival
5 years
Study Arms (2)
1 Control group
ACTIVE COMPARATORControl group: \*Docetaxel 75 mg/m2, and cisplatin 75 mg/m2, both on day 1, every 21 days. Total cycles: Four.
2 Experimental group
EXPERIMENTALExperimental 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.
Interventions
Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles
Gemcitabine 1250 mg/m2, day 1 and 8 and cisplatin 75 mg/m2 day 1, 4 cycles
Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
Hospital de Elche
Elche, Alicante, 03202, Spain
Ico - H. Germans Trias I Pujol
Badalona, Barcelona, 08916, Spain
Hospital D'Althaia
Manresa, Barcelona, 08243, Spain
Hospital de Mataró
Mataró, Barcelona, 08034, 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, 15076, Spain
Hospital San Pedro
Logroño, La Rioja, 26004, Spain
F.H.Alcorcon
Alcorcón, Madrid, 28922, Spain
Hospital Severo Ochoa
Leganés, Madrid, 28911, Spain
Hospital Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital de La Ribera
Alzira, Valencia, 46600, Spain
Hospital de Cruces
Barakaldo, Vizcaya, 48903, Spain
Hospital de Basurto
Bilbao, Vizcaya, Spain
H.G.U. Alicante
Alicante, 03010, Spain
Hospital de La Santa Creu I Sant Pau
Barcelona, 08025, Spain
Hospital Clínic de Barcelona
Barcelona, 08036, Spain
Hospital Univ. Sagrat Cor
Barcelona, 08036, Spain
Instituto Universitario Dexeus
Barcelona, 28036, Spain
Hospital Reina Sofía
Córdoba, 14004, Spain
Ico-Girona (Hospital Josep Trueta)
Girona, 17007, Spain
Hospital Virgen de Las Nieves
Granada, 18015, Spain
Hospital de Jaén
Jaén, 23007, Spain
Hospital de León
León, Spain
Hospital Arnau de Vilanova
Lleida, 46015, Spain
Hospital 12 de Octubre
Madrid, 28006, Spain
Hospital Clínico San Carlos
Madrid, 28006, Spain
Hospital de La Princesa
Madrid, 28006, Spain
Md Anderson Internacional
Madrid, 28033, Spain
Fundación Jiménez Díaz
Madrid, 28040, Spain
Hospital La Paz
Madrid, 28046, Spain
Hospital Puerta de Hierro
Madrid, 28222, Spain
Hospital Carlos Haya
Málaga, 29010, Spain
Hospital Morales Messeguer
Murcia, 30008, Spain
Clínica Rotger
Palma de Mallorca, 07012, Spain
Hospital Son Dureta
Palma de Mallorca, 07014, Spain
Hospital Son Llátzer
Palma de Mallorca, 07198, Spain
Hospital Clinico de Salamanca
Salamanca, 37007, Spain
Hospital de Donostia
San Sebastián, 20014, Spain
Instituto Oncológico de San Sebastián
San Sebastián, Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Spain
H. Arnau de Vilanova
Valencia, 46015, Spain
Hospital General de Valencia
Valencia, Spain
Instituto Valenciano de Oncología
Valencia, Spain
Hospital Provincial de Zamora
Zamora, 49012, Spain
Hospital Lozano Blesa
Zaragoza, Spain
Hospital Miguel Servet
Zaragoza, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Eva Pereira
- Organization
- Fundación GECP
Study Officials
- STUDY CHAIR
Bartomeu Massutí Sureda, MD
Hospital General Universitario de Alicante
- STUDY CHAIR
Jose Miguel Sanchez Torres, MD
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2007
First Posted
May 25, 2007
Study Start
June 1, 2007
Primary Completion
June 1, 2015
Study Completion
July 1, 2015
Last Updated
December 12, 2024
Results First Posted
December 12, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share