TS Gene Polymorphism Predicts Effect in Patients With Advanced Lung Cancer (TPEIAL)

Hunan Province Tumor Hospital

Status and phase: Completed; Phase 2

Conditions: Adenocarcinoma; Non-small-cell Lung Cancer

Treatments: Drug: pemetrexed

Study type: Interventional

Funder types: Other

Identifiers

NCT00940069

LYN-LC-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

TS high expression genotype

Experimental group

Description:

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.

Treatment:

Drug: pemetrexed

TS low expression genotype

Experimental group

Description:

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.

Treatment:

Drug: pemetrexed