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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00864266
Other study ID # 01082
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2009
Est. completion date June 2020

Study information

Verified date June 2020
Source European Lung Cancer Working Party
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date June 2020
Est. primary completion date June 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Intervention

Drug:
Chemotherapy
Standard cisplatin-based chemotherapy in agreement with the ELCWP guidelines (available on the website www.elcwp.org)

Locations

Country Name City State
Belgium Department of Pneumology Clinique Saint-Luc Bouge
Belgium Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet Brussels
Belgium Service de Pneumologie Hôpital Erasme Brussels
Belgium Department of Pneumology Hôpital Saint-Joseph Gilly
Belgium Hôpital Ambroise Paré Mons
Belgium Department of Pneumology Centre Hospitalier de Mouscron Mouscron

Sponsors (1)

Lead Sponsor Collaborator
European Lung Cancer Working Party

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Response rate response will be assessed every 3 cycles of chemotherapy according to WHO criteria
Secondary Survival Survival will be dated from the date of treatment
Secondary Progression-free survival Period between the date of treatment and the date of first progression or death
Secondary Duration of response period between the day of treatment and the date of first progression in patients with an objective response
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