Painful Non-Bone-Metastasis tumors
Conditions
Interventions
Standard Treatment (Arm A)
Each participating site shall select one of the following fractionation schedules at the time of study enrollment:
1. 4 Gy per fraction, once daily, 5 fractions per week
Sponsors
Saito Tetsuo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) The patient is aged 18 years or older at the time of enrollment. 2) The patient has a histologically confirmed diagnosis of solid cancer (excluding hematologic malignancies such as lymphoma and multiple myeloma). 3) The patient has a painful non-bone-metastasis tumor with a Numerical Rating Scale (NRS) score of 2 or higher. 4) If the patient has other sources of pain, each has a lower NRS score than the protocol-designated lesion. 5) The cause of pain is not brain metastasis. 6) The protocol-designated lesion has not been previously irradiated. 7) The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3. 8) No local treatment with the intent of prolonging survival is planned for the protocol-designated lesion. 9) The protocol-designated lesion is not a case of multiple hepatocellular carcinomas or liver metastases for which whole-liver-irradiation is planned. 10) Written informed consent has been obtained from the patient.
Exclusion criteria
Exclusion criteria: 1) Patients with serious comorbidities, such as infections, heart failure, hepatic failure, renal failure, collagen diseases, or psychiatric disorders, who are deemed unsuitable for participation in the study. 2) Patients with psychiatric disorders that may interfere with study participation. 3) Patients who are pregnant, breastfeeding, or may possibly be pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Two-month overall pain response rate in all enrolled patients (intention-to-treat analysis) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Two-month complete pain response rate 2) Six-month and twelve-month overall pain response rates 3) Six-month and twelve-month complete pain response rates 4) Presence or absence of pain unrelated to the protocol-designated lesion 5) Treatment completion rate 6) Duration of pain response 7) Re-irradiation rate 8) Adverse events 9) Quality of life (EQ-5D-5L) 10) Cost 11) Overall survival | — |
Contacts
Public ContactNobuki Imano
Hiroshima University Hospital
Outcome results
None listed