drugset / Trial / NCT03067792

FOLFIRI Versus Docetaxel and Cisplatin as a Second-line Chemotherapy After Failure of First-line Chemotherapy in Advanced Gastric Cancer

NCT03067792 ↗

Phase 3 Completed 52 enrolled Yonsei University
RandomizedParallel-groupTreatment

Summary

Patients diagnosis with inoperable gastric cancers are treated with palliative chemotherapy. Palliative chemotherapy had proven to be better overall survivals and quality of life in unresectable advanced gastric cancer. NCCN guideline suggested two or three drug cytotoxic regimen as a first line therapy. But response rate of those regimens is about 50 percent. Disappointingly most of cases are about to experience progression of disease. Second line regimens of palliative chemotherapy are also have shown its efficacy and recommended within patients with better performance status. But There is still lack of evidences in gastric cancer patients second line chemotherapy. Several phase II trial those subjects are 2nd line palliative chemotherapy in gastric cancer had suggested that irinotecan, taxane, oxaliplatin, oral fluorouracil.Investigator assessed whether cisplatin in combination with paclitaxel would increase response rate in patient previously treated for advanced gastric cancer compared with FOFIRI regimen.

Timeline

Start
2014-12
Primary completion
2016-10-17
Completion
2016-10-17

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cisplatin Other / unclassified 75 mg/m2 Intravenous
Comparator Docetaxel Small molecule 75 mg/m2 Intravenous
Comparator Irinotecan Small molecule 180 mg/m2 Intravenous
Comparator Leucovorin Small molecule 200 mg/m2 Intravenous
Comparator fluorouracil Small molecule 600 mg/m2 Intravenous

Indications