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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

Effect of Genetic Polymorphisms on Clinical Outcome of Platinum Based Chemotherapy in Non-Small Cell Lung Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03154242
• Other study ID #: PHCL137
• Status: Recruiting
• Phase: N/A
• First received: May 9, 2017
• Last updated: May 13, 2017
• Start date: March 20, 2017
• Est. completion date: December 2018

Study information

• Verified date: May 2017
• Source: Ain Shams University
• Contact: demonstrator of clinical pharmacy
• Phone: 01151958437
• Email: esraa.salah[@]pharm.asu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Egypt	Al Demerdash Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)	It's defined as the time from day 1 of chemotherapy to the day of documented disease progression or death from any cause.	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