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

Primary Purpose

Inoperable Gastric Cancer

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

5-fluorouracil, irinotecan and leucovorin

docetaxel and cisplatin

About this trial

This is an interventional treatment trial for Inoperable Gastric Cancer focused on measuring inoperable gastric cancer, palliative chemotherapy

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Older than 19 years old and younger than 75 years old
Pathologically confirmed gastric cancer
Inoperable stage at diagnosis
experienced diseases progression in first line palliative chemotherapy
ECOG performance status 0 or 1
Adequate renal function (serum creatinine < 1.5 mg/dL or calculated creatinine clearance ≥ 60 ml/min)
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)
Adequate BM function (WBC ≥ 3,500/µl, absolute neutrophil cell count ≥ 1,500 /µl, platelet count ≥ 100,000/µl)
Subjects who given written informed consent after being given a full description of the study

Exclusion Criteria:

double primary cancer other than gastric cancer
history of palliative radiation therapy
Pregnant or on breast feeding
Neuropathy grade > 3
Active infection
Symptomatic cardiopulmonary diseases
Active hepatitis of liver cirrhosis
Impaired renal function
Impaired psychologic bone marrow function
Psychologic disorder, Severe neurologic disorder.
hypersensitivity to chemotherapeutic agent

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

FOLFIRI

Arm Description

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

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

Outcomes

Primary Outcome Measures

response rate

CT examination would be done at 7~8 weeks after initiation of 1st cycle chemotherapeutic agent, After 2 cycle of chemotherapy in DP group and 3cyle of chemotherapy in FOFIRI group.

Secondary Outcome Measures

diseases control rate

disease control, defined as the proportion of patients who had a best response of complete response, partial response, or stable

Overall survival

overall survival, defined as time from randomisation to death

progression free survival

progression-free survival, defined as time from randomisation to radiographic progression or death

Full Information

NCT ID

NCT03067792

First Posted

February 22, 2017

Last Updated

February 28, 2017

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT03067792

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

December 2014 (Actual)

Primary Completion Date

October 17, 2016 (Actual)

Study Completion Date

October 17, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inoperable Gastric Cancer

Keywords

inoperable gastric cancer, palliative chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FOLFIRI

Arm Type

Active Comparator

Arm Description

Arm Title

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

5-fluorouracil, irinotecan and leucovorin

Intervention Description

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

Intervention Name(s)

docetaxel and cisplatin

Intervention Description

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

Primary Outcome Measure Information:

Title

response rate

Description

CT examination would be done at 7~8 weeks after initiation of 1st cycle chemotherapeutic agent, After 2 cycle of chemotherapy in DP group and 3cyle of chemotherapy in FOFIRI group.

Time Frame

up to 2 year

Secondary Outcome Measure Information:

Title

diseases control rate

Description

disease control, defined as the proportion of patients who had a best response of complete response, partial response, or stable

Time Frame

up to 2 year

Title

Overall survival

Description

overall survival, defined as time from randomisation to death

Time Frame

up to 2 year

Title

progression free survival

Description

progression-free survival, defined as time from randomisation to radiographic progression or death

Time Frame

up to 2 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Older than 19 years old and younger than 75 years old Pathologically confirmed gastric cancer Inoperable stage at diagnosis experienced diseases progression in first line palliative chemotherapy ECOG performance status 0 or 1 Adequate renal function (serum creatinine < 1.5 mg/dL or calculated creatinine clearance ≥ 60 ml/min) 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) Adequate BM function (WBC ≥ 3,500/µl, absolute neutrophil cell count ≥ 1,500 /µl, platelet count ≥ 100,000/µl) Subjects who given written informed consent after being given a full description of the study Exclusion Criteria: double primary cancer other than gastric cancer history of palliative radiation therapy Pregnant or on breast feeding Neuropathy grade > 3 Active infection Symptomatic cardiopulmonary diseases Active hepatitis of liver cirrhosis Impaired renal function Impaired psychologic bone marrow function Psychologic disorder, Severe neurologic disorder. hypersensitivity to chemotherapeutic agent

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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