Unresectable Advanced Cancers and Metastasized or Relapsed Solid Tumors(Breast cancer, lung cancer, stomach cancer, colon cancer, squamous cell carcinoma of the head and neck, liver cancer, endometrial cancer, ovarian cancer)
Conditions
Interventions
[Monitoring arm] ePRO monitoring will be conducted once weekly after study enrollment. The monitoring will concern treatment of each predefined type of cancer or characteristic symptoms of the condit
severe"
for individual symptoms. When it is reported that a threshold value has been exceeded, an alert notification will be sent to the study staff member assigned to the patient. The (sub)investigator who r
Sponsors
Public Health Research Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Unresectable, advanced, metastasized, or relapsed solid tumors (2) Expected to be able to undergo treatment or observation for at least 6 months at the study site (3) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2 (4) Receiving systemic anticancer mono- or combination pharmacotherapy (e.g., cytotoxic anticancer agents, molecularly targeted drugs, and immune checkpoint inhibitors) at enrollment or scheduled to begin such therapy within 1 month from the date of enrollment (In principle, patients should be receiving pharmacotherapy on an out-patient basis.) (5) Capable of using electronic device (includes cases needing some assistance) (6) Aged >=18 at informed consent (7) Written consent for the study personally obtained from the subject
Exclusion criteria
Exclusion criteria: (1) Has undergone four or more regimens of pharmacotherapy for advanced, metastasized, or relapsed solid tumors*Notes 1, 2 (2) Currently participating in a study where PRO is tracked and the results are passed on to a physician (3) The following are exclusion criteria for individual types of cancer 1) Breast cancer - Scheduled to receive or currently receiving endocrine therapy (including endocrine therapy in combination with other agents) for hormone receptor-positive breast cancer - Scheduled to receive or currently receiving first regimen of anti-HER2 therapy for HER2-positive disease 2) Liver cancer - Hepatic function of Child-Pugh B/C (4) Ongoing or planned radical radiotherapy (5) Deemed otherwise unsuitable for the study by the investigator or sub-investigator *Notes: 1. If the disease has relapsed during perioperative adjuvant chemotherapy or within 24 weeks after adjuvant chemotherapy, the adjuvant chemotherapy will be considered as the first regimen of adjuvant chemotherapy. 2. Does not include endocrine therapy for breast cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) OS (2) HRQoL The global health status score on the The European Organization for Research and Treatment of Cancer QLQ-C30 (EORTC QLQ-C30) at all measurement time points to Week 24 after enrollment | — |
Countries
Japan
Contacts
Public ContactAkira Yamao
Public Health Research Foundation Office of Comprehensive Support Project for Oncology Research (CSPOR)
Outcome results
None listed