NCT03061058

Individualized Intraperitoneal and System Chemotherapy Versus System Chemotherapy as First-line Chemotherapy for AGC

An Open-label, Randomized, Phase III, Multicenter Clinical Trial Comparing the Efficacy and Safety of Individualized Intraperitoneal and System Chemotherapy Versus System Chemotherapy as First-line Chemotherapy for Advanced Gastric Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Tumor messenger ribonucleic acid (mRNA) expression levels may have a promising role as potential predictive biomarkers for chemotherapy. Peritoneal carcinomatosis appears to be the most common pattern of metastasis or recurrence and is associated with poor prognosis in gastric cancer patients. Intraperitoneal chemotherapy is widely accepted strategy in the treatment of peritoneal dissemination. In this study, our aim is to evaluate the impact of individualized selection of chemotherapeutics and intraperitoneal combined with system chemotherapy on overall survival, disease free survival, response rate, and safety of advanced gastric cancer patients.

Conditions

• Stomach Neoplasms
• Chemotherapy Effect
• Chemotherapeutic Toxicity

Interventions

Type	Name	Description
DRUG	Docetaxel	intraperitoneal and/or intravenous
DRUG	Oxaliplatin	intravenous
DRUG	Cisplatin	intraperitoneal
DRUG	Irinotecan	intraperitoneal and/or intravenous
DRUG	Pemetrexed	intraperitoneal and/or intravenous
DRUG	S1	oral

Timeline

• Start date: 2013-04-01
• Primary completion: 2018-12-01
• Completion: 2019-12-01
• First posted: 2017-02-23
• Last updated: 2017-09-15

Locations

8 sites across 1 country: China