search
Back to results

Individualized Treatment Based on Epidermal Growth Factor Receptor Mutations and Level of BRCA1 Expression in Advanced Adenocarcinoma (SLAT)

Primary Purpose

Non-small Cell Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Docetaxel
Cisplatin
Gemcitabine
Erlotinib
Sponsored by
Spanish Lung Cancer Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Non-small Cell Lung Cancer focused on measuring NSCLC

Eligibility Criteria

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

Inclusion Criteria:

  • Patients age 18 years or more.

  • Histologically confirmed diagnosis of non-small-cell lung carcinoma.(and indifferentiated and BAC histology).

    • Only patients with advanced disease, defined as stage IV or IIIB with/without pleural effusion, will be included.
    • Tumor sample available.
    • A measurable lesion, as defined by RECIST criteria.
    • Karnofsky score 60% or more (ECOG < 2).
    • Patients should not have received previous treatment with chemotherapy or other agents for disseminated disease. Chemotherapy is allowed if the initial diagnosis of the patient is limited disease and the patient has received adjuvant or neoadjuvant treatment.
  • Patients with cerebral disease are permitted, without any time limitations after holocranial irradiation or complementary antiedema treatment.
  • Patients with hepatical, renal and hematology normality values.
  • Patients should sign an informed consent form before inclusion in the study that specifies that the clinical trial treatment entails consent for the analysis of biological samples of tumor and blood.
  • Patients of childbearing age of either sex must use effective contraceptive methods (barrier methods or other birth control methods) before entering the study and while participating in the study.
  • Patients must be available for clinical follow-up..

Exclusion Criteria:

  • Patients who have received an investigational medicinal product in the 21 days before inclusion in the study or antiEGFR receptor agent.
  • Severe comorbidity.

Sites / Locations

  • Ico-Hospital Universitarios Germans Trias I Pujol
  • Hospital Carlos Haya

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

2

1

Arm Description

The rest of the patients who do not carry the Factor Receptor mutation of Epidermal Growth will receive chemotherapy treatment individualized based on BRCA 1 m RNA levels. Function of these levels, three different subgroups of treatment: Subgroup A with low BRCA1 mRNA levels will receive treatment with gemcitabine / cisplatin Subgroup B with intermediate levels of BRCA1 mRNA: will receive treatment with docetaxel / cisplatin Subgroup C with high levels of BRCA1 mRNA: will receive treatment with docetaxel

The group of patients carrying EGFR mutation will receive treatment with Erlotinib, a selective oral Receptor tyrosine kinase inhibitor Epidermal Growth Factor

Outcomes

Primary Outcome Measures

Tumoral Response (RECIST criteria)
To evaluate the tumor response of the treatment as measured by investigator-assessed overall response rate according to RECIST v1.1.

Secondary Outcome Measures

Overall Survival
Time from randomization until death from any cause. Patients who have not died during the study will be tabulated on their last date of evaluation.

Full Information

First Posted
December 22, 2008
Last Updated
June 8, 2022
Sponsor
Spanish Lung Cancer Group
search

1. Study Identification

Unique Protocol Identification Number
NCT00883480
Brief Title
Individualized Treatment Based on Epidermal Growth Factor Receptor Mutations and Level of BRCA1 Expression in Advanced Adenocarcinoma
Acronym
SLAT
Official Title
Tratamiento Individualizado en función de Las Mutaciones en EGFR y Del Nivel de expresión de BRCA1 en Pacientes Con Adenocarcinoma de pulmón Avanzado
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a pharmacogenic, prospective, and multicenter study in patients with advanced lung adenocarcinoma.
Detailed Description
Pharmacogenomic study, prospective, multicenter. Individualized treatment based on EGFR mutations and level of BRCA1 expression in patients with advanced lung adenocarcinoma

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
NSCLC

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Experimental
Arm Description
The rest of the patients who do not carry the Factor Receptor mutation of Epidermal Growth will receive chemotherapy treatment individualized based on BRCA 1 m RNA levels. Function of these levels, three different subgroups of treatment: Subgroup A with low BRCA1 mRNA levels will receive treatment with gemcitabine / cisplatin Subgroup B with intermediate levels of BRCA1 mRNA: will receive treatment with docetaxel / cisplatin Subgroup C with high levels of BRCA1 mRNA: will receive treatment with docetaxel
Arm Title
1
Arm Type
Experimental
Arm Description
The group of patients carrying EGFR mutation will receive treatment with Erlotinib, a selective oral Receptor tyrosine kinase inhibitor Epidermal Growth Factor
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
Docetaxel 75 mg/day 1 x 4 cycles
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Platinol
Intervention Description
Docetaxel-Cisplatin 75 mg/day 1 x 4 cycles
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
Cisplatin 75 mg/ day 1 x 4 cycles Gemcitabine 1250 mg/ day 1 and 8 x 4 cycles
Intervention Type
Drug
Intervention Name(s)
Erlotinib
Other Intervention Name(s)
Tarceva
Intervention Description
Erlotinib 150 mg/day x 21 days
Primary Outcome Measure Information:
Title
Tumoral Response (RECIST criteria)
Description
To evaluate the tumor response of the treatment as measured by investigator-assessed overall response rate according to RECIST v1.1.
Time Frame
From date of end of experimental treatment until the date of last follow up, assessed up to 24 months]
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Time from randomization until death from any cause. Patients who have not died during the study will be tabulated on their last date of evaluation.
Time Frame
From the date of randomization to the date of last follow up or death, assessed up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients age 18 years or more. Histologically confirmed diagnosis of non-small-cell lung carcinoma.(and indifferentiated and BAC histology). Only patients with advanced disease, defined as stage IV or IIIB with/without pleural effusion, will be included. Tumor sample available. A measurable lesion, as defined by RECIST criteria. Karnofsky score 60% or more (ECOG < 2). Patients should not have received previous treatment with chemotherapy or other agents for disseminated disease. Chemotherapy is allowed if the initial diagnosis of the patient is limited disease and the patient has received adjuvant or neoadjuvant treatment. Patients with cerebral disease are permitted, without any time limitations after holocranial irradiation or complementary antiedema treatment. Patients with hepatical, renal and hematology normality values. Patients should sign an informed consent form before inclusion in the study that specifies that the clinical trial treatment entails consent for the analysis of biological samples of tumor and blood. Patients of childbearing age of either sex must use effective contraceptive methods (barrier methods or other birth control methods) before entering the study and while participating in the study. Patients must be available for clinical follow-up.. Exclusion Criteria: Patients who have received an investigational medicinal product in the 21 days before inclusion in the study or antiEGFR receptor agent. Severe comorbidity.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafael Rosell, MD
Organizational Affiliation
ICO-HOSPITAL GERMANS TRIAS I PUJOL
Official's Role
Study Chair
Facility Information:
Facility Name
Ico-Hospital Universitarios Germans Trias I Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Carlos Haya
City
Málaga
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
19415121
Citation
Rosell R, Perez-Roca L, Sanchez JJ, Cobo M, Moran T, Chaib I, Provencio M, Domine M, Sala MA, Jimenez U, Diz P, Barneto I, Macias JA, de Las Penas R, Catot S, Isla D, Sanchez JM, Ibeas R, Lopez-Vivanco G, Oramas J, Mendez P, Reguart N, Blanco R, Taron M. Customized treatment in non-small-cell lung cancer based on EGFR mutations and BRCA1 mRNA expression. PLoS One. 2009;4(5):e5133. doi: 10.1371/journal.pone.0005133. Epub 2009 May 5.
Results Reference
derived
Links:
URL
http://www.gecp.org
Description
Web page of the sponsor where users can find more information about Fundación GECP studies

Learn more about this trial

Individualized Treatment Based on Epidermal Growth Factor Receptor Mutations and Level of BRCA1 Expression in Advanced Adenocarcinoma

We'll reach out to this number within 24 hrs