advanced gastric cancer
Conditions
Interventions
None listed
Sponsors
St.Marianna University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients fulfilling the following criteria will be enrolled: Patients who: - Are >20 years old, - Have histologically confirmed advanced gastric adenocarcinoma, - Have advanced gastric cancer with evaluable lesions, - Are scheduled to receive combination chemotherapy with ramucirumab and a taxane, - Can use electric devices (PCs, tablets, or mobile phones/cell phones) at home, and - Have provided written informed consent.
Exclusion criteria
Exclusion criteria: Patients fulfilling any of the following criteria will not be enrolled in any component of the study. Patients who: - Are unable to receive nutrition orally, - Have documented and/or symptomatic brain or leptomeningeal metastases, - Have experienced any episodes of Grade 3-4 gastrointestinal bleeding within 3 months prior to enrollment, - Have experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina within 6 months prior to enrollment, - Have an ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, uncontrolled thrombotic or hemorrhagic disorder, or any other serious uncontrolled medical disorders in the opinion of the investigator, - Have an ongoing or active psychiatric illness or a social situation that would limit compliance with the study requirements, - Have uncontrolled or poorly controlled hypertension despite standard medical management, - Have had a serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to enrollment, - Have undergone major surgery within 28 days prior to randomization or the placement of a subcutaneous venous access device within 7 days prior to enrollment, - Are receiving chronic antiplatelet therapy including the use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others), dipyridamole, clopidogrel, or similar agents with the exception of once-daily aspirin use (maximum dose, 325 mg/day), and - Are scheduled to receive elective or planned major surgery during the course of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight control rate at 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR and PFS of chemotherapy, OS, Safety, PG-SGA, FAACT | — |
Countries
Japan
Contacts
Public ContactTakuro Mizukami
St.Marianna University School of Medicine Department of Clinical Oncolgy
Outcome results
None listed