Spots Global Cancer Trial Database for A Phase 2 Trial of Optimizing Platinum-Based Chemotherapy Based on ERCC1 Expression as First-Line Treatment in Patients With Locally Advanced or Metastatic Gastric Cancer
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Trial Identification
Brief Title: A Phase 2 Trial of Optimizing Platinum-Based Chemotherapy Based on ERCC1 Expression as First-Line Treatment in Patients With Locally Advanced or Metastatic Gastric Cancer
Official Title: A Prospective, Multi-Center, Randomized Control Phase 2 Trial of Optimizing Platinum-Based Chemotherapy Based on ERCC1 Expression as First-Line Treatment in Patients With Locally Advanced or Metastatic Gastric Cancer
Study ID: NCT01967875
Conditions
Study Description
Brief Summary: The purpose of this study is to determine whether ERCC1(excision repair cross-complementation 1 ) expression has effects on platinum-based chemotherapy for patients with locally advanced or metastatic gastric cancer, and to explore if ERCC1 can act as a biological predictor for the individual therapy of gastric cancer
Detailed Description: This is a prospective, multi-center, randomized control clinical trial, aimed to demonstrate if ERCC1 expression could predict the efficacy of platinum-based chemotherapy in patients with locally advanced or metastatic gastric cancer. A total of 180 patients are planned to be enrolled into the study. ERCC1 protein expression in paraffin-embedding tumor tissue is examined by immunohistochemistry (IHC). Patients with low ERCC1 expression (group L) will be treated with XP regimen. Patients with high ERCC1 expression will be randomized into group H-A or group H-B, and be treated with XP or DX regimen, respectively. The primary end point is progression free survival (PFS), and the secondary end points include the median overall survival, objective response rate (ORR),disease control rate(DCR), duration of response, safety(number and degree of adverse events), and the quality of life (QOL).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The Fourth Hospital of Anshan, Anshan, Liaoning, China
The First Hospital of Dalian Medical University, Dalian, Liaoning, China
The Second Hospital of Dalian Medical University, Dalian, Liaoning, China
The First Hospital of Liaoning Medical University, Jinzhou, Liaoning, China
The First Hospital of China Medical University, Shenyang, Liaoning, China
Liaoning Tumor Hospital, Shenyang, Liaoning, China
Shengjing Hospital of China Medical University, Shenyang, Liaoning, China
Contact Details
Name: Yunpeng Liu, MD., PhD
Affiliation: China Medical University, China
Role: PRINCIPAL_INVESTIGATOR
Name: Xiujuan Qu, MD.,PhD.
Affiliation: China Medical University, China
Role: PRINCIPAL_INVESTIGATOR
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