metastatic or advanced gastric cancer
Conditions
Interventions
Two packs (600kcal) intake of elemental diet (Elental) is orally performed a day. An administration period makes it every day from the start dates (the first course Day 1) till the end of the first-l
Sponsors
NPO Hokkaido Gastrointestinal Cancer Study Group (HGCSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with histologically proven unresectable progression or relapse gastric cancer. (2) Patients with the following regimen as first-line treatment, S-1 + cisplatin, capecitabine + cisplatin, capecitabine + cisplatin + trastuzumab (3) Patients in whom oral intake of staple food is possible during a study periods (4) Aged 20 or older (5) ECOG performance status 0-2 (6) Patients by whom the survival for three months or more is anticipated from the registration. (7) Written informed consent obtained. <<laboratory evidence>> 1) Hemoglobin >= 8.0g/dL 2) Neutrophil counts >= 1,000/mm3 or white blood cell counts >= 2,000/mm3 3) Platelet counts >= 75,000 /mm3 4) T-Bil <= 3mg /dL 5) AST or ALT < 150 IU/L 6) Creatinine clearance >= 50 mL/min (it computes based on a Cockcroft-Gault equation).
Exclusion criteria
Exclusion criteria: (1) Patients who recieved nutritional therapy for one week or more within the past two months (2) Patient who took L-glutamine quantity content drugs (marzulene, GFO, etc.) for less than two weeks of past. (3) Patients who are associated with uncontrollable abnormal glucose tolerance (4) Patients who are associated with critical complications (5) Pregnancy and lactation, and/or without intention of birth control. (6) Patients with mental disorders (7) Patients applicable to contraindications of each use drugs. (8) Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Treatment Failure | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Incidence of adverse events (particularly stomatitis incidences, diarrhoea incidence, etc.), 2) Body weight change, 3) Serum albumin change, 4) Relative dose intensity, 5) Safety, 6) Compliance of elemental diet, 7) The number of first-line cycles, 8) response of the tumor, 9) Progression free survival, 10) Overall survival | — |
Countries
Japan
Contacts
Public ContactNao Horie
Hokkaido University Hospital Department of Clinical Trial Management
Outcome results
None listed