Randomized Customized Adjuvant Chemotherapy (GECP-SCAT) (GECP-SCAT)

October 28, 2024 updated by: Spanish Lung Cancer Group

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain, 03010
        • H.G.U. Alicante
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08025
        • Hospital de La Santa Creu i Sant Pau
      • Barcelona, Spain, 08036
        • Hospital Univ. Sagrat Cor
      • Barcelona, Spain, 28036
        • Instituto Universitario Dexeus
      • Córdoba, Spain, 14004
        • Hospital Reina Sofía
      • Girona, Spain, 17007
        • Ico-Girona (Hospital Josep Trueta)
      • Granada, Spain, 18015
        • Hospital Virgen de las Nieves
      • Jaén, Spain, 23007
        • Hospital de Jaen
      • Leon, Spain
        • Hospital de León
      • Lleida, Spain, 46015
        • Hospital Arnau de Vilanova
      • Madrid, Spain, 28040
        • Fundación Jiménez Díaz
      • Madrid, Spain, 28046
        • Hospital La Paz
      • Madrid, Spain, 28006
        • Hospital de La Princesa
      • Madrid, Spain, 28222
        • Hospital Puerta de Hierro
      • Madrid, Spain, 28006
        • Hospital 12 de Octubre
      • Madrid, Spain, 28006
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28033
        • Md Anderson Internacional
      • Malaga, Spain, 29010
        • Hospital Carlos Haya
      • Murcia, Spain, 30008
        • Hospital Morales Messeguer
      • Palma de Mallorca, Spain, 07198
        • Hospital Son Llatzer
      • Palma de Mallorca, Spain, 07012
        • Clínica Rotger
      • Palma de Mallorca, Spain, 07014
        • Hospital Son Dureta
      • Salamanca, Spain, 37007
        • Hospital Clínico de Salamanca
      • San Sebastián, Spain, 20014
        • Hospital de Donostia
      • San Sebastián, Spain
        • Instituto Oncológico de San Sebastián
      • Santa Cruz de Tenerife, Spain
        • Hospital Universitario de Canarias
      • Valencia, Spain
        • Instituto Valenciano de Oncología
      • Valencia, Spain
        • Hospital General de Valencia
      • Valencia, Spain, 46015
        • H. Arnau de Vilanova
      • Zamora, Spain, 49012
        • Hospital Provincial de Zamora
      • Zaragoza, Spain
        • Hospital Lozano Blesa
      • Zaragoza, Spain
        • Hospital Miguel Servet
    • Alicante
      • Elche, Alicante, Spain, 03202
        • Hospital de Elche
    • Asturias
      • Oviedo, Asturias, Spain
        • Hospital Central de Asturias
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • ICO - H. Germans Trias i Pujol
      • Manresa, Barcelona, Spain, 08243
        • Hospital D'Althaia
      • Mataró, Barcelona, Spain, 08034
        • Hospital de Mataró
    • Castellón
      • Castellón De La Plana, Castellón, Spain
        • Hospital Provincial de Castellon
    • GRAN Canaria
      • Las Palmas de Gran Canaria, GRAN Canaria, Spain
        • Hospital Insular de Gran Canaria
    • LA Coruna
      • Santiago de Compostela, LA Coruna, Spain, 15076
        • Hospital Clin. Univ. Santiago de Compostela
    • LA Rioja
      • Logrono, LA Rioja, Spain, 26004
        • Hospital San Pedro
    • Madrid
      • Alcorcon, Madrid, Spain, 28922
        • F.H.Alcorcón
      • Leganés, Madrid, Spain, 28911
        • Hospital Severo Ochoa
    • Valencia
      • Alzira, Valencia, Spain, 46600
        • Hospital de la Ribera
    • Vizcaya
      • Baracaldo, Vizcaya, Spain, 48903
        • Hospital De Cruces
      • Bilbao, Vizcaya, Spain
        • Hospital de Basurto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1 Control group

Control group:

*Docetaxel 75 mg/m2, and cisplatin 75 mg/m2, both on day 1, every 21 days. Total cycles: Four.
Drug: Docetaxel/Cisplatin control
Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles
Other Names:
  • Taxotere/Platinol
Experimental: 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.
Drug: Docetaxel/Cisplatin
Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles
Other Names:
  • Taxotere/Platinol
Drug: Docetaxel
Docetaxel 75 mg/m2 day 1, 4 cycles
Other Names:
  • Taxotere
Drug: Gemcitabine/Cisplatin
Gemcitabine 1250 mg/m2, day 1 and 8 and cisplatin 75 mg/m2 day 1, 4 cycles
Other Names:
  • Gemzar/Platinol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimated Overall Survival
Time Frame: 5 years

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Free Survival
Time Frame: 5 years
To assess the disease-free survival of both treatment groups. Disease-free survival: will be calculated from the date of surgery until there is some clinical evidence of disease progression or the date of death due to the disease.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

May 24, 2007

First Submitted That Met QC Criteria

May 24, 2007

First Posted (Estimated)

May 25, 2007

Study Record Updates

Last Update Posted (Actual)

December 12, 2024

Last Update Submitted That Met QC Criteria

October 28, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GECP-SCAT
  • 2007-000067-15 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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