Clinical trial NCT00864266: 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
Overall status: COMPLETED
Phase: NA
Conditions: Non Small Cell Lung Carcinoma
Keywords: Non small cell lung carcinoma
Chemotherapy
Response prediction
Lead sponsor: European Lung Cancer Working Party
Sponsor class: OTHER
First posted: 2009-03-18
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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)

Primary outcomes:
measure: Response rate
timeFrame: response will be assessed every 3 cycles of chemotherapy according to WHO criteria
Secondary outcomes:
measure: Survival
timeFrame: Survival will be dated from the date of treatment
measure: Progression-free survival
timeFrame: Period between the date of treatment and the date of first progression or death
measure: Duration of response
timeFrame: period between the day of treatment and the date of first progression in patients with an objective response
Other outcomes:
Locations:
city: Bouge
country: Belgium
facility: Department of Pneumology Clinique Saint-Luc
city: Brussels
country: Belgium
facility: Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
city: Brussels
country: Belgium
facility: Service de Pneumologie Hôpital Erasme
city: Gilly
country: Belgium
facility: Department of Pneumology Hôpital Saint-Joseph
city: Mons
country: Belgium
facility: Hôpital Ambroise Paré
city: Mouscron
country: Belgium
facility: Department of Pneumology Centre Hospitalier de Mouscron
Study officials:
affiliation: European Lung Cancer Working Party
name: Thierry Berghmans, MD
role: STUDY_CHAIR
References:
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.
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.