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

Not Applicable

Completed

• Conditions: Non Small Cell Lung Carcinoma
• Interventions: Drug: Chemotherapy

• Registration Number: NCT00864266
• Lead Sponsor: European Lung Cancer Working Party

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-16
• Study First Submitted QC: 2009-03-17
• Study First Posted: 2009-03-18
• Status Verified: 2020-06
• Primary Completion: 2020-06
• Study Completion: 2020-06
• Last Update Submitted: 2020-06-25
• Last Update Posted: 2020-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Chemotherapy	After 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)

Primary Outcome Measures

Name	Time	Method
Response rate	response will be assessed every 3 cycles of chemotherapy according to WHO criteria

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (6)

Hôpital Ambroise Paré; 🇧🇪 Mons, 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

Department of Pneumology Centre Hospitalier de Mouscron; 🇧🇪 Mouscron, Belgium