Biological Factors Predicting Response to Chemotherapy in Advanced Non Small Cell Lung Cancer

Non Small Cell Lung Carcinoma Clinical Trial

Official title:

Biological Factors Predicting Response to Chemotherapy in Advanced Non Small Cell Lung Cancer : a Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00864266
• Other study ID #: 01082
• Status: Completed
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Carcinoma

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