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

NCT ID: NCT03067792

Last Updated: 2017-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-10-17

Brief 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.

Conditions

Inoperable Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT

Study Groups

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

Group Type: ACTIVE_COMPARATOR

5-fluorouracil, irinotecan and leucovorin

Intervention Type: 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.

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

Group Type: ACTIVE_COMPARATOR

docetaxel and cisplatin

Intervention Type: DRUG

In DP group, patients received docetaxel 75 mg/m2 and cisplatin 75mg/m2 intravenously on days 1 of a 21-day cycle.

Interventions

5-fluorouracil, irinotecan and leucovorin

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.

Intervention Type: DRUG

docetaxel and cisplatin

In DP group, patients received docetaxel 75 mg/m2 and cisplatin 75mg/m2 intravenously on days 1 of a 21-day cycle.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Older than 19 years old and younger than 75 years old

2. Pathologically confirmed gastric cancer

3. Inoperable stage at diagnosis

4. experienced diseases progression in first line palliative chemotherapy

5. ECOG performance status 0 or 1

6. Adequate renal function (serum creatinine < 1.5 mg/dL or calculated creatinine clearance ≥ 60 ml/min)

7. Adequate liver function (total bilirubin < 1.5 X the upper limits of normal (ULN), AST and ALT <3 X UNL, and alkaline phosphatases < 3 X ULN or < 5 x ULN in case of liver involvement)

8. Adequate BM function (WBC ≥ 3,500/µl, absolute neutrophil cell count ≥ 1,500 /µl, platelet count ≥ 100,000/µl)

9. Subjects who given written informed consent after being given a full description of the study

Exclusion Criteria

1. double primary cancer other than gastric cancer

2. history of palliative radiation therapy

3. Pregnant or on breast feeding

4. Neuropathy grade > 3

5. Active infection

6. Symptomatic cardiopulmonary diseases

7. Active hepatitis of liver cirrhosis

8. Impaired renal function

9. Impaired psychologic bone marrow function

10. Psychologic disorder, Severe neurologic disorder.

11. hypersensitivity to chemotherapeutic agent

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

4-2014-0626

Identifier Type: -

Identifier Source: org_study_id