TS Gene Polymorphism Predicts Effect in Patients With Advanced Lung Cancer

Adenocarcinoma Clinical Trial

— TPEIAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00940069
• Other study ID #: LYN-LC-001
• Status: Completed
• Phase: Phase 2
• First received: July 14, 2009
• Last updated: February 19, 2016
• Start date: March 2009
• Est. completion date: January 2015

Study information

• Verified date: February 2016
• Source: Hunan Province Tumor Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2015
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small-cell Lung Cancer

Intervention

Drug:
• pemetrexed
'TS high expression genotype': pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 on day 1 of each 21 day,for not less than 4 cycle, administered intravenously every 3 weeks. 'TS low expression genotype': pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 on day 1 of each 21 day,for not less than 4 cycle, administered intravenously every 3 weeks.

Locations

Country	Name	City	State
China	HuNan province tumor hospital	ChangSha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Hunan Province Tumor Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

Krawczyk P, Kucharczyk T, Kowalski DM, Powrózek T, Ramlau R, Kalinka-Warzocha E, Winiarczyk K, Knetki-Wróblewska M, Wojas-Krawczyk K, Kalakucka K, Dyszkiewicz W, Krzakowski M, Milanowski J. Polymorphisms in TS, MTHFR and ERCC1 genes as predictive markers — View Citation

Wang X, Wang Y, Wang Y, Cheng J, Wang Y, Ha M. Association of thymidylate synthase gene 3'-untranslated region polymorphism with sensitivity of non-small cell lung cancer to pemetrexed treatment: TS gene polymorphism and pemetrexed sensitivity in NSCLC. J — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to progress		6 months	No
Secondary	overall survival		1 year	No