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

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00864266
Recruitment Status : Active, not recruiting
First Posted : March 18, 2009
Last Update Posted : January 31, 2018
Information provided by (Responsible Party):
European Lung Cancer Working Party

Brief Summary:
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 or disease Intervention/treatment
Non Small Cell Lung Carcinoma Drug: Chemotherapy

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
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
Study Start Date : March 2009
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
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)

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

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

Information from the National Library of Medicine

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

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)

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

Department of Pneumology Clinique Saint-Luc
Bouge, Belgium, 5004
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
Brussels, Belgium, 1000
Service de Pneumologie Hôpital Erasme
Brussels, Belgium, 1070
Department of Pneumology Hôpital Saint-Joseph
Gilly, Belgium, 6060
Hôpital Ambroise Paré
Mons, Belgium, 7000
Department of Pneumology Centre Hospitalier de Mouscron
Mouscron, Belgium, 7700
Sponsors and Collaborators
European Lung Cancer Working Party
Study Chair: Thierry Berghmans, MD European Lung Cancer Working Party

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 Posted: March 18, 2009    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by European Lung Cancer Working Party:
Non small cell lung carcinoma
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
Lung Diseases
Respiratory Tract Diseases