Advanced solid tumors for which treatments recommended by practice guidelines have been completed or are no longer available (breast cancer, lung cancer, stomach cancer, colon cancer, hepatobiliary pancreatic cancer, gynecologic cancer, urologic cancer)
Conditions
Interventions
Physician'
s choice of drug therapy will be given to the study treatment group.
Best supportive care (BSC), the standard of care, will be given to the study control group.
Sponsors
Aichi Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically diagnosed with solid cancer (breast cancer, lung cancer, stomach cancer, colorectal cancer, hepatobiliary pancreatic cancer [hepatocellular carcinoma, biliary tract cancer (intrahepatic bile duct cancer, extrahepatic bile duct cancer, gallbladder cancer, duodenal papillary cancer), pancreatic cancer], gynecological cancer [ovarian cancer, fallopian tube cancer, peritoneal cancer, cervical cancer, uterine cancer (including sarcoma)], urological cancer [prostate cancer, renal cancer, urothelial cancer]). 2) Advanced, metastatic, or recurrent cancer that is not resectable or radically irradiated. 3) Judged by attending physician that drug therapy is not aggressively recommended since all therapies recommended in the practice guidelines have been completed or judged to be unavailable. 4) There are drug therapies that are not recommended by practice guidelines but can be used. 5) Not scheduled to undergo gene panel testing. 6) 18 years and over at enrollment. 7) Performance status (PS) is 0, 1, or 2 according to ECOG criteria. 8) No measurable lesions are required. 9) No symptomatic brain metastases and no spinal metastases requiring radiation or surgical procedures. 10) Able to make outpatient visits. 11) Preserved organ function to receive drug therapies. 12) Able to complete QOL surveys using an electronic device. 13) Patient's written consent to participate in the study has been obtained.
Exclusion criteria
Exclusion criteria: 1) Infectious disease requiring physical treatment. 2) Psychiatric disorders/symptoms that interfere with daily life and make it difficult to participate in the study. 3) Pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding. 4) Judged difficult to participate in the study by the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) EORTC QLQ-C30 score 2) EQ-5D-5L score 3) Health Economics 4) Quality-adjusted life years (QALYs) 5) Length of hospital stay up to 12 weeks after enrollment 6) Number of scheduled outpatient visits up to 12 weeks after enrollment 7) Number of emergency room and unscheduled outpatient visits up to 12 weeks after enrollment | — |
Countries
Japan
Contacts
Public ContactAtsuko Nakasato
Public Health Research Foundation Comprehensive Support Project for Oncology Research
Outcome results
None listed