JCOG2211: A randomized phase III study comparing re-irradiation stereotactic body radiotherapy and conventional radiotherapy for painful spinal metastases

JRCT ID: jRCT1030240172

Registered date:18/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Painful spinal metastases with a history of prior irradiation
• Date of first enrollment: 18/06/2024
• Target sample size: 156
• Study type: Interventional

Intervention(s)

Arm A: conventional radiotherapy of 8 Gy in a single fraction
Arm B: Stereotactic body radiotherapy of 24 Gy in2 fractions

Outcome(s)

• Primary Outcome: Complete pain response rate in targeted spinal metastases at 12 weeks
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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 84 days since the final irradiation date of the previous radiotherapy
(iii) The prescribed dose was 40 Gy (an equivalent dose at 2 Gy [EQD2], alpha/beta = 2 Gy) or less and 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

Exclude 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.

Related Information

• Primary Sponsor: NAKAMURA Naoki
• Source(s) of Monetary Support: National Cancer Center Japan