drugset / Trial / NCT03061058
Individualized Intraperitoneal and System Chemotherapy Versus System Chemotherapy as First-line Chemotherapy for AGC
Phase 3
Unknown
240 enrolled
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2013-04-01
- Primary completion
- 2018-12
- Completion
- 2019-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 25 mg/m2 | Intrathecal |
| Subject | Docetaxel | Small molecule | 15 mg/m2 | Intrathecal |
| Subject | Docetaxel | Small molecule | 30 mg/m2 | Intrathecal |
| Subject | Docetaxel | Small molecule | 45 mg/m2 | Intrathecal |
| Subject | Docetaxel | Small molecule | 90 mg/m2 | Intrathecal |
| Subject | Irinotecan | Small molecule | 45 mg/m2 | Intrathecal |
| Subject | Oxaliplatin | Small molecule | 75 mg/m2 | Intrathecal |
| Subject | Pemetrexed | Small molecule | 150 mg/m2 | Intrathecal |
| Subject | Pemetrexed | Small molecule | 350 mg/m2 | Intrathecal |
| Subject | S-1 | Small molecule | 40 mg/m2 | Intrathecal |