Clinical trial NCT03067792: FOLFIRI Versus Docetaxel and Cisplatin as a Second-line Chemotherapy After Failure of First-line Chemotherapy in Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Inoperable Gastric Cancer
Keywords: inoperable gastric cancer
palliative chemotherapy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-03-01
Enrollment: 52
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: response rate
timeFrame: up to 2 year
Secondary outcomes:
measure: diseases control rate
timeFrame: up to 2 year
measure: Overall survival
timeFrame: up to 2 year
measure: progression free survival
timeFrame: up to 2 year
Other outcomes:
Locations:
Study officials:
References: