Back to resultsBiological Factors Predicting Response to Chemotherapy in Advanced Non Small Cell Lung Cancer
Primary Purpose
Non Small Cell Lung Carcinoma
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Chemotherapy
Sponsored by
About this trial
This is an interventional diagnostic trial for Non Small Cell Lung Carcinoma focused on measuring Non small cell lung carcinoma, Chemotherapy, Response prediction
Eligibility 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)
Sites / Locations
- Department of Pneumology Clinique Saint-Luc
- Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
- Service de Pneumologie Hôpital Erasme
- Department of Pneumology Hôpital Saint-Joseph
- Hôpital Ambroise Paré
- Department of Pneumology Centre Hospitalier de Mouscron
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
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)
Outcomes
Primary Outcome Measures
Response rate
Secondary Outcome Measures
Survival
Progression-free survival
Duration of response
Full Information
NCT ID
NCT00864266
First Posted
March 16, 2009
Last Updated
June 25, 2020
Sponsor
European Lung Cancer Working Party
1. Study Identification
Unique Protocol Identification Number
NCT00864266
Brief Title
Biological Factors Predicting Response to Chemotherapy in Advanced Non Small Cell Lung Cancer
Official Title
Biological Factors Predicting Response to Chemotherapy in Advanced Non Small Cell Lung Cancer : a Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
March 2009 (Actual)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
June 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Lung Cancer Working Party
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Carcinoma
Keywords
Non small cell lung carcinoma, Chemotherapy, Response prediction
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Intervention Description
Standard cisplatin-based chemotherapy in agreement with the ELCWP guidelines (available on the website www.elcwp.org)
Primary Outcome Measure Information:
Title
Response rate
Time Frame
response will be assessed every 3 cycles of chemotherapy according to WHO criteria
Secondary Outcome Measure Information:
Title
Survival
Time Frame
Survival will be dated from the date of treatment
Title
Progression-free survival
Time Frame
Period between the date of treatment and the date of first progression or death
Title
Duration of response
Time Frame
period between the day of treatment and the date of first progression in patients with an objective response
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry Berghmans, MD
Organizational Affiliation
European Lung Cancer Working Party
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Pneumology Clinique Saint-Luc
City
Bouge
ZIP/Postal Code
5004
Country
Belgium
Facility Name
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Service de Pneumologie Hôpital Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Department of Pneumology Hôpital Saint-Joseph
City
Gilly
ZIP/Postal Code
6060
Country
Belgium
Facility Name
Hôpital Ambroise Paré
City
Mons
ZIP/Postal Code
7000
Country
Belgium
Facility Name
Department of Pneumology Centre Hospitalier de Mouscron
City
Mouscron
ZIP/Postal Code
7700
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25674536
Citation
Berghmans T, Ameye L, Lafitte JJ, Colinet B, Cortot A, CsToth I, Holbrechts S, Lecomte J, Mascaux C, Meert AP, Paesmans M, Richez M, Scherpereel A, Tulippe C, Willems L, Dernies T, Leclercq N, Sculier JP; European Lung Cancer Working Party. Prospective Validation Obtained in a Similar Group of Patients and with Similar High Throughput Biological Tests Failed to Confirm Signatures for Prediction of Response to Chemotherapy and Survival in Advanced NSCLC: A Prospective Study from the European Lung Cancer Working Party. Front Oncol. 2015 Jan 28;4:386. doi: 10.3389/fonc.2014.00386. eCollection 2014.
Results Reference
derived
PubMed Identifier
24007627
Citation
Berghmans T, Ameye L, Willems L, Paesmans M, Mascaux C, Lafitte JJ, Meert AP, Scherpereel A, Cortot AB, Cstoth I, Dernies T, Toussaint L, Leclercq N, Sculier JP; European Lung Cancer Working Party. Identification of microRNA-based signatures for response and survival for non-small cell lung cancer treated with cisplatin-vinorelbine A ELCWP prospective study. Lung Cancer. 2013 Nov;82(2):340-5. doi: 10.1016/j.lungcan.2013.07.020. Epub 2013 Aug 7.
Results Reference
derived
Learn more about this trial
Biological Factors Predicting Response to Chemotherapy in Advanced Non Small Cell Lung Cancer
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