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Spots Global Cancer Trial Database for Genotype Guided Chemotherapy in Gastric Cancer Patients

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Trial Identification

Brief Title: Genotype Guided Chemotherapy in Gastric Cancer Patients

Official Title: TSER Genotype Guided Chemotherapy in Metastatic Gastric Cancer Patients: A Phase II Study in China

Study ID: NCT02204306

Interventions

TSER

Study Description

Brief Summary: In gastric cancer patients treated with 5-FU and cisplatin, higher tumor TS levels were associated with a less favorable response (29% vs. 68%; p=0.024). Similarly, in a study in which patients were treated with high dose 5-FU, patients with high TS expression had a response rate of only 12.5%. Conversely a response rate of 92.9% was observed in patients with low tumor TS expression. A longer but not statistically significant survival advantage was observed in patients with the TSER\*2 allele compared with the TSER\*3/\*3 patients. Additionally, a review by Patel et al. identified approximately 20 gastric cancer studies that have found a positive association between TSER genotype and clinical response (in either direction). Therefore, the primary goal of this proposal is to prospectively genotype patients, select patients with "good risk" TSER genotypes (TSER\*2\*/\*2 or \*2/\*3) and treat them with a standard 5-FU containing regimen (FOLFOX) in order to improve clinical outcomes, while randomize patients with the "poor risk" TSER genotype (\*3/\*3) to either the standard 5-FU containing regimen or another non-5-FU-based regimen (docetaxel/cisplatin).

Detailed Description:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Institute of Clinical Pharmacology, Changsha, Hunan, China

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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