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

Conditions

• Inoperable Gastric Cancer

Eligibility Criteria

Sex

ALL

Age

19 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• 5-fluorouracil, irinotecan and leucovorin — DRUG
  In FOLFIRI group, patients received irinotecan 180 mg/m2 and 5-fluorouracil 400mg/m2 intravenously bolus injection on days 1 and leucovorin 200mg/m2 for 2 hours and 5-fluorouracil 600mg/m2 for 22 hours intravenously infusion on day 2 of a 14-day cycle.
• docetaxel and cisplatin — DRUG
  In DP group, patients received docetaxel 75 mg/m2 and cisplatin 75mg/m2 intravenously on days 1 of a 21-day cycle.

Study Details

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.

Key Dates

Start date

Dec 31, 2014

Status verified

Feb 2017

Primary completion

Oct 17, 2016

Completion

Oct 17, 2016

Study Design

Enrollment

52 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: FOLFIRI
  2nd palliative chemotherapy with FOLFIRI regimen,In FOLFIRI group, patients received irinotecan 180 mg/m2 and 5- fluorouracil 400mg/m2 intravenously bolus injection on days 1 and leucovorin 200mg/m2 for 2 hours and 5-fluorouracil 600mg/m2 for 22 hours intravenously infusion on day 2 of a 14-day cycle. Response evaluation would be done after 3 cycle of chemotherapy in DP group
• Active Comparator: DP
  2nd palliative chemotherapy with Docetaxel/cisplatin regimen, In DP group, patients received docetaxel 75 mg/m2 and cisplatin 75mg/m2 intravenously on days 1 of a 21-day cycle. Response evaluation would be done after 2 cycle of chemotherapy in DP group

Primary Outcome Measure

response rate [ Time Frame: up to 2 year ]