Biological Factors Predicting Response to Chemotherapy in Advanced Non Small Cell Lung Cancer
1 other identifier
interventional
70
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2009
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 16, 2009
CompletedFirst Posted
Study publicly available on registry
March 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedJune 26, 2020
June 1, 2020
11.3 years
March 16, 2009
June 25, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response rate
response will be assessed every 3 cycles of chemotherapy according to WHO criteria
Secondary Outcomes (3)
Survival
Survival will be dated from the date of treatment
Progression-free survival
Period between the date of treatment and the date of first progression or death
Duration of response
period between the day of treatment and the date of first progression in patients with an objective response
Study Arms (1)
1
EXPERIMENTALAfter 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)
Interventions
Standard cisplatin-based chemotherapy in agreement with the ELCWP guidelines (available on the website www.elcwp.org)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Department of Pneumology Clinique Saint-Luc
Bouge, 5004, Belgium
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
Brussels, 1000, Belgium
Service de Pneumologie Hôpital Erasme
Brussels, 1070, Belgium
Department of Pneumology Hôpital Saint-Joseph
Gilly, 6060, Belgium
Hôpital Ambroise Paré
Mons, 7000, Belgium
Department of Pneumology Centre Hospitalier de Mouscron
Mouscron, 7700, Belgium
Related Publications (2)
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.
PMID: 25674536DERIVEDBerghmans 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.
PMID: 24007627DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Thierry Berghmans, MD
European Lung Cancer Working Party
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2009
First Posted
March 18, 2009
Study Start
March 1, 2009
Primary Completion
June 1, 2020
Study Completion
June 1, 2020
Last Updated
June 26, 2020
Record last verified: 2020-06