Clinical trial NCT00940069: TS Gene Polymorphism Predicts Effect in Patients With Advanced Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small-cell Lung Cancer
Adenocarcinoma
Keywords: TS
polymorphism
lung cancer
adenocarcinoma
pemetrexed
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
First posted: 2009-07-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: time to progress
timeFrame: 6 months
Secondary outcomes:
measure: overall survival
timeFrame: 1 year
Other outcomes:
Locations:
city: ChangSha
country: China
facility: HuNan province tumor hospital
state: Hunan
Study officials:
affiliation: Hunan Province Tumor Hospital
name: Yi Luo, doctor
role: STUDY_CHAIR
affiliation: Hunan Province Tumor Hospital
name: Nong Yang, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krawczyk P, Kucharczyk T, Kowalski DM, Powrozek T, Ramlau R, Kalinka-Warzocha E, Winiarczyk K, Knetki-Wroblewska M, Wojas-Krawczyk K, Kalakucka K, Dyszkiewicz W, Krzakowski M, Milanowski J. Polymorphisms in TS, MTHFR and ERCC1 genes as predictive markers in first-line platinum and pemetrexed therapy in NSCLC patients. J Cancer Res Clin Oncol. 2014 Dec;140(12):2047-57. doi: 10.1007/s00432-014-1756-6. Epub 2014 Jul 16.
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 Biomed Sci. 2013 Jan 25;20(1):5. doi: 10.1186/1423-0127-20-5.