Inoperable Gastric Cancer Clinical Trial
| Verified date | February 2017 |
| Source | Yonsei University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 52 |
| Est. completion date | October 17, 2016 |
| Est. primary completion date | October 17, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 19 Years to 75 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | up to 2 year | |
| Secondary | diseases control rate | disease control, defined as the proportion of patients who had a best response of complete response, partial response, or stable | up to 2 year | |
| Secondary | Overall survival | overall survival, defined as time from randomisation to death | up to 2 year | |
| Secondary | progression free survival | progression-free survival, defined as time from randomisation to radiographic progression or death | up to 2 year |