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A Multicenter, Open Clinical Trial of Using TS Gene Polymorphism to Predict Effect in Patients of Advanced Lung Adenocarcinoma to Pemetrexed Combining With Cisplatin Regiment as First-line Treatment


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Advanced Lung Cancer, Chemotherapy

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Trial Information

A Multicenter, Open Clinical Trial of Using TS Gene Polymorphism to Predict Effect in Patients of Advanced Lung Adenocarcinoma to Pemetrexed Combining With Cisplatin Regiment as First-line Treatment


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 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 of all
patients.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

time to progress

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Yi Luo, doctor

Investigator Role:

Study Chair

Investigator Affiliation:

Hunan Province Tumor Hospital

Authority:

China: Food and Drug Administration

Study ID:

LYN-LC-001

NCT ID:

NCT00940069

Start Date:

March 2009

Completion Date:

December 2010

Related Keywords:

  • Advanced Lung Cancer
  • Chemotherapy
  • TS
  • polymorphism
  • lung cancer
  • adenocarcinoma
  • pemetrexed
  • Adenocarcinoma
  • Lung Neoplasms

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