Effect of Genetic Polymorphisms on Platinum Based Chemotherapy in Non Small Cell Lung Cancer

• Conditions: Carcinoma, Non-Small-Cell Lung

• Registration Number: NCT03154242
• Lead Sponsor: Ain Shams University

Brief Summary

This Study evaluate the effect of Polymorphism in the Excision repair cross-complementing group 5 (ERCC5) (rs1047768 and rs751402) gene on the clinical outcome of Platinum-based regimens used in the treatment of Non-Small Cell Lung Cancer (NSCLC) patients

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-20
• Status Verified: 2017-05
• Study First Submitted: 2017-05-09
• Study First Submitted QC: 2017-05-13
• Last Update Submitted: 2017-05-13
• Study First Posted: 2017-05-16
• Last Update Posted: 2017-05-16
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Newly diagnosed with immunohistochemically and pathologically confirmed non-small cell lung cancer (NSCLC).
2. Eastern Cooperative Oncology Group performance status (ECOG PS) = 0-2.
3. Chemotherapy naïve.
4. Age >18 years.
5. Adequate bone marrow reserve

Exclusion Criteria

1. Presence of Central nervous system(CNS) metastases.
2. Inadequate liver function
3. Inadequate renal function
4. Serious comorbid systemic disorder incompatible with the study.
5. Pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	From the date of starting the chemotherapy until the date of documented disease progression or date of death from any cause assessed up to 12 months	It's defined as the time from day 1 of chemotherapy to the day of documented disease progression or death from any cause.

Trial Locations

Locations (1)

Al Demerdash Hospital; 🇪🇬 Cairo, Egypt