Painful spinal metastases with a history of prior irradiation
Conditions
Interventions
Arm A: conventional radiotherapy of 8 Gy in a single fraction
Arm B: Stereotactic body radiotherapy of 24 Gy in2 fractions
Sponsors
NAKAMURA Naoki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Feasibility of plain MRI (2) Histologically proven solid cancer excluding seminoma, malignant lymphoma, and multiple myeloma (3) Diagnosed with spinal metastases (cervical, thoracic, lumbar, sacral, coccygeal spine) through plain MRI or contrast-enhanced CT, and no spinal cord compression (Bilsky Grade 1c or lower) (4) Sites or number of metastases in other organs apart from spinal metastases are not specified. No curative local treatment is planned for all metastatic lesions. (5) Aged 18 years or older (6) ECOG performance status is either (i) or (ii) below: (i) PS 0 - 2 (ii) PS 3 due to pain caused by spinal metastases (7) Either a single vertebra or two adjacent vertebrae for targeted spinal metastases. (8) Pain caused by targeted spinal metastases is rated at NRS 2 or higher. In case of cancer-related pain from other than targeted spinal metastases, the NRS is lower than pain caused by targeted spinal metastases. (9) Analgesics are appropriately administered for the pain caused by targeted spinal metastases (Pain Management Index is 0 or higher). (10) History of radiotherapy for targeted spinal metastases meets all the following: (i) Conventional radiotherapy excluding SBRT (ii) At least 56 days since the final irradiation date of the previous radiotherapy; however, if the previous radiotherapy exceeded the standard dose (30 Gy/10 fractions = 37.5 Gy EQD2), at least 84 days is required (iii) The prescribed dose was 40 Gy (an equivalent dose at 2 Gy [EQD2], alpha/beta = 2 Gy) or less, or the maximum dose to the spinal cord or cauda equina was 46.2 Gy (EQD2, alpha/beta = 2 Gy) or less (11) No prior surgery for targeted spinal metastases (12) Written informed consent from patient
Exclusion criteria
Exclusion criteria: (1) Infectious disease requiring systemic treatment. (2) Body temperature of 38 degrees Celsius or higher. (3) Female during pregnancy, or with pregnancy potential. Males with partners planning conception shortly. (4) Psychological disorder difficult to participate in this clinical study. (5) Severe emphysema, interstitial pneumonia, or pulmonary fibrosis based on chest CT in patients with thoracic spinal metastases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete pain response rate in targeted spinal metastases at 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain response rate in targeted spinal metastases at 4/12/24/48 weeks, QOL score, cumulative incidence rate of local failure, cumulative incidence rate of spinal cord compression, overall survival and toxicities | — |
Contacts
Public ContactNaoki NAKAMURA
St.Marianna University School of Medicine
Outcome results
None listed