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Biological Factors Predicting Response to Chemotherapy in Advanced Non Small Cell Lung Cancer

This study is currently recruiting participants.
Verified August 2016 by European Lung Cancer Working Party
Sponsor:
ClinicalTrials.gov Identifier:
NCT00864266
First Posted: March 18, 2009
Last Update Posted: August 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
European Lung Cancer Working Party
  Purpose
The primary aim of the study is to identify a predictive molecular signature for response to chemotherapy, according to WHO criteria, in patients with non-small cell lung cancer by studying the transcriptome (miRNAs and mRNAs) and the single nucleotide polymorphism (SNPs) by using high throughput techniques.

Condition Intervention
Non Small Cell Lung Carcinoma Drug: Chemotherapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Biological Factors Predicting Response to Chemotherapy in Advanced Non Small Cell Lung Cancer : a Prospective Study

Resource links provided by NLM:


Further study details as provided by European Lung Cancer Working Party:

Primary Outcome Measures:
  • Response rate [ Time Frame: response will be assessed every 3 cycles of chemotherapy according to WHO criteria ]

Secondary Outcome Measures:
  • Survival [ Time Frame: Survival will be dated from the date of treatment ]
  • Progression-free survival [ Time Frame: Period between the date of treatment and the date of first progression or death ]
  • Duration of response [ Time Frame: period between the day of treatment and the date of first progression in patients with an objective response ]

Estimated Enrollment: 70
Study Start Date: March 2009
Estimated Study Completion Date: March 2021
Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
After obtaining the biopsy, patients will be treated by standard chemotherapy (the regimen has to be in agreement with the ELCWP guidelines, available on the website www.elcwp.org)
Drug: Chemotherapy
Standard cisplatin-based chemotherapy in agreement with the ELCWP guidelines (available on the website www.elcwp.org)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological diagnosis of non-small-cell lung cancer (NSCLC)
  • Obtention of a biopsy of the tumour according to the procedure defined in the protocol
  • NSCLC of any stage to be treated by standard conventional first-line chemotherapy, as defined in the ELCWP guidelines (www.elcwp.org)
  • Presence of at least one assessable lesion
  • Availability for participating in the detailed follow-up of the protocol
  • Signed informed consent.
  • Age above 18 years

Exclusion Criteria:

  • Patient who was previously treated with chemotherapy for NSCLC or who has any contra-indication precluding the administration of conventional chemotherapy for NSCLC
  • NSCLC treated by exclusive surgery or radiotherapy
  • A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or of the bladder or cured malignant tumour (more than 5-year disease free interval)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00864266


Contacts
Contact: Nathalie Leclercq, RN 0032/2/5390496 nathalie.leclercq@bordet.be
Contact: Thierry Berghmans, MD 0032/2/5390496

Locations
Belgium
Department of Pneumology Clinique Saint-Luc Recruiting
Bouge, Belgium, 5004
Contact: Oswald Van Cutsem, MD         
Principal Investigator: Oswald Van Cutsem, MD         
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet Recruiting
Brussels, Belgium, 1000
Contact: Thierry Berghmans, MD    0032/2/5390496      
Principal Investigator: Thierry Berghmans, MD         
Service de Pneumologie Hôpital Erasme Recruiting
Brussels, Belgium, 1070
Contact: Paul deVuyst, MD, PhD         
Contact: Dimitri Leducq, MD         
Principal Investigator: Paul deVuyst, MD         
Department of Pneumology Hôpital Saint-Joseph Recruiting
Gilly, Belgium, 6060
Contact: Benoît Colinet, MD         
Principal Investigator: Benoît Colinet, MD         
Hôpital Ambroise Paré Recruiting
Mons, Belgium, 7000
Contact: Stéphane Holbrechts, MD         
Sub-Investigator: Patricia Wackenier, MD         
Principal Investigator: Stéphane Holbrechts, MD         
Department of Pneumology Centre Hospitalier de Mouscron Recruiting
Mouscron, Belgium, 7700
Contact: Christian Tulippe, MD         
Principal Investigator: Christian Tulippe, MD         
Sponsors and Collaborators
European Lung Cancer Working Party
Investigators
Study Chair: Thierry Berghmans, MD European Lung Cancer Working Party
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: European Lung Cancer Working Party
ClinicalTrials.gov Identifier: NCT00864266     History of Changes
Other Study ID Numbers: 01082
First Submitted: March 16, 2009
First Posted: March 18, 2009
Last Update Posted: August 10, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by European Lung Cancer Working Party:
Non small cell lung carcinoma
Chemotherapy
Response prediction

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases