Study to Evaluate Treatment Customized According to RAP80 and BRCA1 in Patients With Advanced Lung Carcinoma (BREC)

January 29, 2024 updated by: Spanish Lung Cancer Group

Multicenter Phase III, Randomized Study to Evaluate Treatment Customized According to RAP80 and BRCA1 Assessment in Patients With Advanced Non-small-cell Lung Cancer

Primary objective:

· Progression free survival.

Secondary objectives:

  • Assess Overall survival of both treatment groups.
  • Assess Tumor response rate using RECIST criteria
  • Assess Toxicity profile of patients enrolled in the study.
  • Exploratory evaluation of potential genetic markers of response or resistance to chemotherapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study population:

Patients with advanced non-small-cell lung cancer who have not received treatment for the disease at this stage and who have a good performance status (ECOG 0-1) and measurable disease (at least one target lesion according to RECIST criteria).

Duration of treatment:

Six chemotherapy cycles will be given. The duration of every cycle will be 21 days. If the treatment is beneficial, it may be prolonged to a total of 8 cycles at the discretion of the investigator.

Calendar and planned finalization date:

The approximate duration of the study is 3 years of recruitment followed by 1 year of follow-up.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
382

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • A Coruña, Spain, 15006
        • H. Juan Canalejo
      • A Coruña, Spain, 15706
        • H. Santiago de Compostela
      • Alicante, Spain, 03010
        • H. Gral. Alicante
      • Almería, Spain, 04009
        • Hospital Torrecardenas
      • Almería, Spain, 04009
        • H. Torrecárdenas
      • Barcelona, Spain
        • Hospital del Mar
      • Barcelona, Spain, 08041
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain, 08036
        • H. Universitario Quirón Dexeus
      • Barcelona, Spain, 08907
        • H. Duran i Reynals-ICO
      • Barcelona, Spain, 08036
        • H. Clínic i Provincial
      • Burgos, Spain, 09005
        • Hospital General Yague
      • Castelló, Spain, 12002
        • H. Provincial de Castellón
      • Girona, Spain, 17007
        • Hospital Universitari de Girona Dr. Josep Trueta
      • Granada, Spain, 18014
        • Hospital Virgen de las Nieves
      • Jaén, Spain, 23007
        • Hospital Ciudad de Jaén
      • Madrid, Spain, 28040
        • Fundacion Jimenez Diaz
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain
        • Hospital Gregorio Marañón
      • Madrid, Spain, 28035
        • H.U. Puerta de Hierro
      • Madrid, Spain, 28006
        • H. de la Princesa
      • Murcia, Spain, 30008
        • Hospital Morales Messeguer
      • Málaga, Spain, 29010
        • Hospital Virgen de la Victoria
      • Málaga, Spain, 29010
        • Hospital Carlos Haya
      • Palma De Mallorca, Spain, 07120
        • Hospital Son Dureta/ Ses Espases
      • Palma De Mallorca, Spain, 07198
        • H. Son Llatzer
      • Sevilla, Spain, 41014
        • Hospital Nuestra Señora de Valme
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia
      • Valencia, Spain
        • H. Gen. Univ. Valencia
      • Valencia, Spain
        • Hospital Arnau De Vilanova
      • Vic, Spain, 08500
        • H. General de Vic
      • Zaragoza, Spain, 50009
        • Hospital Clinico Lozano Blesa
      • Zaragoza, Spain, 59009
        • H. Clínico Lozano Blesa
    • Alicante
      • Alcoi, Alicante, Spain, 03804
        • H. Virgen de los Lirios
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • H. Germans Trias i Pujol
      • Manresa, Barcelona, Spain, 08243
        • Hospital D'Althaia
      • Mataró, Barcelona, Spain, 08304
        • Hospital de Mataró
    • Bizkaia
      • Barakaldo, Bizkaia, Spain, 48903
        • Hospital de Cruces
    • Córdoba
      • Cordoba, Córdoba, Spain, 14004
        • Hospital Reina Sofia
    • Madrid
      • Alcorcon, Madrid, Spain, 28922
        • F.H.Alcorcón
      • Leganés, Madrid, Spain, 28911
        • H. Severo Ochoa
      • Pozuelo De Alarcón, Madrid, Spain, Madrid
        • Hospital Universitario Quiron Madrid
      • Pozuelo De Alarcón, Madrid, Spain, 28223
        • Clinica Quiron
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48013
        • Hospital de Basurto
    • Zaragoza
      • Calatayud, Zaragoza, Spain, 50299
        • Hospital Ernest Lluch

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

INCLUSION CRITERIA:

  1. Patients age 18 years or more.
  2. Histologically confirmed diagnosis of non-small-cell lung carcinoma.
  3. Only patients with advanced disease defined as stage IV or IIIB with or without pleural effusion will be included. In the event of IIIB disease without pleural effusion those patients, who for some reason (respiratory disease, large radiation volume...) may not be candidates to have chemotherapy and radiotherapy treatment and may only be treated with chemotherapy, will be considered.
  4. Tumor specimen available (according to the criterion of the specimen-processing laboratory) for the analysis of RAP80 and BRCA1 expression in mRNA.
  5. A measurable lesion, as defined by RECIST criteria.
  6. Karnofsky score 80% or more (ECOG < 2).
  7. No previous treatment with chemotherapy or other agents for disseminated disease. Chemotherapy is allowed if the patient's initial diagnosis is limited disease and the patient has received adjuvant or neoadjuvant treatment, as long as a minimum of 6 months has passed since the end of the adjuvant and/or neo-adjuvant chemotherapy.
  8. Patients with cerebral disease may be included without any time limitations after holocranial irradiation or complementary antiedema treatment, as long as there is correct control of the clinical symptoms arising from the brain disease or is symptomatic.

  9. Patients with the following hematologic values:

    ANC ≥ 1.5 x 109/L Hb ≥ 10 g/dl Platelets ≥ 100 x 109/L

  10. Patients with the following biochemical values:

    Bilirubin ≤ 1.5 mg/dL AST and ALT < 1.5 upper limit of normality Creatinine clearance ≥ 60 ml/min.

  11. 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.
  12. 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 specimens of tumor and blood.
  13. Patients must be available for clinical follow-up.

EXCLUSION CRITERIA

  1. Previous chemotherapy treatment, except the supposition reflected in inclusion criterion 7.
  2. Patients diagnosed of another neoplasm, with the exception of cervical carcinoma in situ, treated squamous cell carcinomas or superficial bladder tumors (Ta and TIS), or other malignant tumors that have received curative treatment within the last 5 years before inclusion in the study.
  3. Patients with serious active bacterial or fungal infective processes from a clinical vantage point (= grade 2 of NCI-CTC, Version 3).
  4. Patients who have received an investigational medicinal product in the 21 days before inclusion in the study.
  5. Patients with HIV infection, HCV infection, coronary artery disease or uncontrolled arrhythmia, uncontrolled cerebrovascular disease, or other clinical conditions that, in the judgment of the investigator, contraindicate the patient's participation in the study.
  6. Patients who are pregnant or breastfeeding. Women of childbearing age must have a negative pregnancy test performed within 7 days before the onset of treatment.
  7. Substance abuse and clinical, psychological or social conditions that can undermine the validity of the informed consent or protocol compliance.
  8. Patients who present any contraindication or suspected allergy to the products under investigation in the study
  9. Impossibility to comply with chemotherapy treatment due to cultural or geographic circumstances.
  10. Significant weight loss (= 10% of body weight) in the 6 weeks before inclusion in the study.
  11. Any condition that is unstable or could endanger the patient's safety and/or the patient's compliance with the study.
  12. Contraindication for steroid use.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: A: Control
Docetaxel 75 mg/m2 and cisplatin 75 mg/m2, both on day 1, every 21 days. Total number of cycles: 6
Drug: Cisplatin, Docetaxel
Docetaxel 75 mg/m2 and cisplatin 75 mg/m2, both on day 1, every 21 days. Total number of cycles: 6
Other Names:
  • Taxotere
  • Platinol
Experimental: B1: Experimental group B1
Low RAP expression and any levels of BRCA1 expression: Gemcitabine 1250 mg/m2, days 1 and 8, and Cisplatin 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6
Drug: Gemcitabine, Cisplatin
Gemcitabine 1250 mg/m2, days 1 and 8, and Cisplatin 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6
Other Names:
  • Gemzar
  • Platinol
Experimental: B2: Experimental group B2
Intermediate or high RAP expression and low or intermediate BRCA1 expression: Docetaxel 75 mg/m2 and Cisplatin 75 mg/m2, both administered on day 1, every 21 days. Total number of cycles: 6
Drug: Docetaxel, Cisplatin
Docetaxel 75 mg/m2 and Cisplatin 75 mg/m2, both administered on day 1, every 21 days. Total number of cycles: 6
Other Names:
  • Taxotere
  • Platinol
Experimental: B3: Experimental group B3
Intermediate or high RAP expression and high BRCA1 expression: Docetaxel 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6
Drug: Docetaxel
Docetaxel 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6
Other Names:
  • Taxotere

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: From the day of start of treatment until first documented progression or death due to any cause,up to 18 months.
Defined as the length of time from the start of treatment to the date of the first documented progression of disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
From the day of start of treatment until first documented progression or death due to any cause,up to 18 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: From the date of start of the treatment until death or end of follow up, up to 18 months.
Defined as the length of time from the start of the treatment that patients diagnosed with the disease are still alive.
From the date of start of the treatment until death or end of follow up, up to 18 months.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Spanish Lung Cancer Group

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rafel Rossell, MD, Principal Investigator of Fundación Grupo Español de Cáncer de Pulmón

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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2008

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GECP-BREC
  • 2007-004278-20 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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