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

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

NAKAMURA Naoki

St.Marianna University School of Medicine

2-16-1, Sugeo, Miyamae-ku, Kawasaki City, Knagawa 216-8511 Japan

naoki.nakamura@marianna-u.ac.jp

NAKAMURA Naoki

St.Marianna University School of Medicine

2-16-1, Sugeo, Miyamae-ku, Kawasaki City, Knagawa 216-8511 Japan

+81-44-977-8111

naoki.nakamura@marianna-u.ac.jp

Recruiting

June. 18, 2024

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

(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

(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.

Both

Painful spinal metastases with a history of prior irradiation

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

Complete pain response rate in targeted spinal metastases at 12 weeks

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

+81-3-3542-2511

April. 18, 2024

No

none