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

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

382

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
      • 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. Clinic i Provincial
      • Burgos, Spain, 09005
        • Hospital General Yagüe
      • 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 Llàtzer
      • Sevilla, Spain, 41014
        • Hospital Nuestra Señora de Valme
      • Valencia, Spain, 46010
        • Hospital Clínico 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 Sofía
    • 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

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
Intervention / Treatment
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

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

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

Spanish Lung Cancer Group

Investigators

  • 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

February 1, 2008

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

February 5, 2008

First Submitted That Met QC Criteria

February 6, 2008

First Posted (Estimated)

February 18, 2008

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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