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

Primary Purpose

Non-small-cell Lung Cancer

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Docetaxel/Cisplatin
Docetaxel
Gemcitabine/Cisplatin
Docetaxel/Cisplatin
Sponsored by
Spanish Lung Cancer Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small-cell Lung Cancer focused on measuring SCAT, BRCA1, BRCA1 mRNA Levels, ADJUVANT, LUNG, GECP-SCAT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital de Elche
  • Hospital Central de Asturias
  • Ico - H. Germans Trias I Pujol
  • Hospital D'Althaia
  • Hospital de Mataró
  • Hospital Insular de Gran Canaria
  • Hospital Clin. Univ. Santiago de Compostela
  • Hospital San Pedro
  • F.H.Alcorcon
  • Hospital Severo Ochoa
  • Hospital de La Ribera
  • Hospital de Cruces
  • Hospital de Basurto
  • H.G.U. Alicante
  • Hospital de La Santa Creu I Sant Pau
  • Hospital Clínic de Barcelona
  • Hospital Univ. Sagrat Cor
  • Instituto Universitario Dexeus
  • Hospital Provincial de Castellón
  • Hospital Reina Sofía
  • Ico-Girona (Hospital Josep Trueta)
  • Hospital Virgen de Las Nieves
  • Hospital de Jaén
  • Hospital de León
  • Hospital Arnau de Vilanova
  • Hospital 12 de Octubre
  • Hospital Clínico San Carlos
  • Hospital de La Princesa
  • Md Anderson Internacional
  • Fundación Jiménez Díaz
  • Hospital La Paz
  • Hospital Puerta de Hierro
  • Hospital Carlos Haya
  • Hospital Morales Messeguer
  • Clínica Rotger
  • Hospital Son Dureta
  • Hospital Son Llátzer
  • Hospital Clinico de Salamanca
  • Hospital de Donostia
  • Instituto Oncológico de San Sebastián
  • Hospital Universitario de Canarias
  • H. Arnau de Vilanova
  • Hospital General de Valencia
  • Instituto Valenciano de Oncología
  • Hospital Provincial de Zamora
  • Hospital Lozano Blesa
  • Hospital Miguel Servet

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Evaluate overall survival

Secondary Outcome Measures

Evaluate the disease-free survival, pattern of recurrences, toxicity profile and potential genetic markers of response and/or resistance to treatment.

Full Information

First Posted
May 24, 2007
Last Updated
July 3, 2015
Sponsor
Spanish Lung Cancer Group
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1. Study Identification

Unique Protocol Identification Number
NCT00478699
Brief Title
Randomized Customized Adjuvant Chemotherapy (GECP-SCAT)
Acronym
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

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spanish Lung Cancer Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small-cell Lung Cancer
Keywords
SCAT, BRCA1, BRCA1 mRNA Levels, ADJUVANT, LUNG, GECP-SCAT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Docetaxel/Cisplatin
Intervention Description
Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Docetaxel 75 mg/m2 day 1, 4 cycles
Intervention Type
Drug
Intervention Name(s)
Gemcitabine/Cisplatin
Intervention Description
Gemcitabine 1250 mg/m2, day 1 and 8 and cisplatin 75 mg/m2 day 1, 4 cycles
Intervention Type
Drug
Intervention Name(s)
Docetaxel/Cisplatin
Intervention Description
Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 day 1, 4 cycles
Primary Outcome Measure Information:
Title
Evaluate overall survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bartomeu Massutí Sureda, MD
Organizational Affiliation
Hospital General Universitario de Alicante
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jose Miguel Sanchez Torres, MD
Organizational Affiliation
HOSPITAL DE LA PRINCESA
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital de Elche
City
Elche
State/Province
Alicante
ZIP/Postal Code
03202
Country
Spain
Facility Name
Hospital Central de Asturias
City
Oviedo
State/Province
Asturias
Country
Spain
Facility Name
Ico - H. Germans Trias I Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital D'Althaia
City
Manresa
State/Province
Barcelona
ZIP/Postal Code
08243
Country
Spain
Facility Name
Hospital de Mataró
City
Mataró
State/Province
Barcelona
ZIP/Postal Code
08034
Country
Spain
Facility Name
Hospital Insular de Gran Canaria
City
Las Palmas de Gran Canaria
State/Province
Gran Canaria
Country
Spain
Facility Name
Hospital Clin. Univ. Santiago de Compostela
City
Santiago de Compostela
State/Province
La Coruna
ZIP/Postal Code
15076
Country
Spain
Facility Name
Hospital San Pedro
City
Logrono
State/Province
La Rioja
ZIP/Postal Code
26004
Country
Spain
Facility Name
F.H.Alcorcon
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Hospital Severo Ochoa
City
Leganés
State/Province
Madrid
ZIP/Postal Code
28911
Country
Spain
Facility Name
Hospital de La Ribera
City
Alzira
State/Province
Valencia
ZIP/Postal Code
46600
Country
Spain
Facility Name
Hospital de Cruces
City
Baracaldo
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital de Basurto
City
Bilbao
State/Province
Vizcaya
Country
Spain
Facility Name
H.G.U. Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital de La Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Univ. Sagrat Cor
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Instituto Universitario Dexeus
City
Barcelona
ZIP/Postal Code
28036
Country
Spain
Facility Name
Hospital Provincial de Castellón
City
Castellón
Country
Spain
Facility Name
Hospital Reina Sofía
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Ico-Girona (Hospital Josep Trueta)
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital Virgen de Las Nieves
City
Granada
ZIP/Postal Code
18015
Country
Spain
Facility Name
Hospital de Jaén
City
Jaén
ZIP/Postal Code
23007
Country
Spain
Facility Name
Hospital de León
City
Leon
Country
Spain
Facility Name
Hospital Arnau de Vilanova
City
Lleida
ZIP/Postal Code
46015
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Md Anderson Internacional
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Fundación Jiménez Díaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Puerta de Hierro
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Carlos Haya
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Morales Messeguer
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Facility Name
Clínica Rotger
City
Palma de Mallorca
ZIP/Postal Code
07012
Country
Spain
Facility Name
Hospital Son Dureta
City
Palma de Mallorca
ZIP/Postal Code
07014
Country
Spain
Facility Name
Hospital Son Llátzer
City
Palma de Mallorca
ZIP/Postal Code
07198
Country
Spain
Facility Name
Hospital Clinico de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital de Donostia
City
San Sebastián
ZIP/Postal Code
20014
Country
Spain
Facility Name
Instituto Oncológico de San Sebastián
City
San Sebastián
Country
Spain
Facility Name
Hospital Universitario de Canarias
City
Santa Cruz de Tenerife
Country
Spain
Facility Name
H. Arnau de Vilanova
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Facility Name
Hospital General de Valencia
City
Valencia
Country
Spain
Facility Name
Instituto Valenciano de Oncología
City
Valencia
Country
Spain
Facility Name
Hospital Provincial de Zamora
City
Zamora
ZIP/Postal Code
49012
Country
Spain
Facility Name
Hospital Lozano Blesa
City
Zaragoza
Country
Spain
Facility Name
Hospital Miguel Servet
City
Zaragoza
Country
Spain

12. IPD Sharing Statement

Links:
URL
http://www.gecp.org
Description
Spanish Lung Cancer Group website

Learn more about this trial

Randomized Customized Adjuvant Chemotherapy (GECP-SCAT)

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