TS Gene Polymorphism Predicts Effect in Patients With Advanced Lung Cancer

Phase 2

Completed

• Conditions: Non-small-cell Lung Cancer; Adenocarcinoma
• Interventions: Drug: pemetrexed

• Registration Number: NCT00940069
• Lead Sponsor: Hunan Province Tumor Hospital

Brief Summary

The investigators performed a multicenter, open trial of using TS gene polymorphism to predict advanced lung adenocarcinoma effect to pemetrexed combined with cisplatin regiment as first-line treatment.

Detailed Description

1. Main eligibility criteria were histologic or cytologic proof of advanced non-small-cell lung cancer (NSCLC) primary treatment, normal organ function, and Eastern Cooperative Oncology Group performance status 0 to 2.

2. All Patients were delivered to pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 for not less than 4 cycle, administered intravenously every 3 weeks. Response assessment was performed every 6 weeks; toxicity assessment was performed every 3 weeks.

3. Primary end point was time to progression (TTP); secondary end points were objective response rate (ORR), overall survival (OS), and toxicity.

4. The study was designed to evaluate TS(thymidylate synthase) gene polymorphism as a predictor for advanced lung adenocarcinoma effect to pemetrexed combined with cisplatin regiment as first-line treatment.

5. Polymorphisms of thymidylate synthase were investigated in peripheral WBC（white blood cell）of all patients.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-07-14
• Study First Submitted QC: 2009-07-14
• Study First Posted: 2009-07-15
• Primary Completion: 2013-06
• Study Completion: 2015-01
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-19
• Last Update Posted: 2016-02-22

Recruitment & Eligibility

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

Inclusion Criteria

• histologic or cytologic proof of advanced lung adenocarcinoma
• primary treatment
• normal organ function
• Eastern Cooperative Oncology Group performance status 0 to 2

Exclusion Criteria

• Symptomatic patients with brain metastases
• Major organ dysfunction and severe heart disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TS high expression genotype	pemetrexed	TS high expression genotype delivered to pemetrexed 500 mg/m2 and cisplatin 75 mg/m2,for not less than 4 cycle, administered intravenously every 3 weeks.
TS low expression genotype	pemetrexed	TS low expression genotype delivered to pemetrexed 500 mg/m2 and cisplatin 75 mg/m2,for not less than 4 cycle, administered intravenously every 3 weeks.

Primary Outcome Measures

Name	Time	Method
time to progress	6 months

Secondary Outcome Measures

Name	Time	Method
overall survival	1 year

Trial Locations

Locations (1)

HuNan province tumor hospital; 🇨🇳 ChangSha, Hunan, China