Non Small Cell Lung Carcinoma
Conditions
Keywords
Non small cell lung carcinoma, Chemotherapy, Response prediction
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.
Interventions
DRUGChemotherapy
Standard cisplatin-based chemotherapy in agreement with the ELCWP guidelines (available on the website www.elcwp.org)
Sponsors
European Lung Cancer Working Party
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | response will be assessed every 3 cycles of chemotherapy according to WHO criteria |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Belgium
Outcome results
None listed