RTOG 631 Phase II/III study of image-guided radiosurgery/SBRT for localized spine metastasis
This is a multi-center phase II/III study for patients who have pain from spine metastasis. The phase II component will determine the feasiblilty of administering image-guided radiosurgery/SBRT treatment in patients with spine metastasis. The phase III component is a randomized study to determine whether image-guided radiosurgery/SBRT improves pain control as compared to conventional external beam radiation. About 12 patients will take part in the phase II component and about 12 patients will take place in the phase III component of the study at UT Southwestern, Parkland Health and amp; Hospital System, and Richardson Regional Cancer Center. The treatment period will last 1 day. For the phase II study follow-up will be at 1 and 3 months from registration. For the phase III study follow-up will be for 24 months from randomization. This study is taking place at a number of other medical facilities around the country. There will be a total of 43 people participating in the phase II component of the research study throughout the United States and/or other countries. 240 patients will participate in the phase III portion of the study. If the patient has met all the eligibility criteria, they will be registered to the study. For phase II, after successful registration to the study and treatment planning session, patients will receive 16 Gy - 18 Gy in 1 fraction, given as image-guided radiosurgery/SBRT, to the prescription line at the edge of the planned treatment volume. Each treatment will last about one hour and will be given in a particular position to help guide the beams of radiation toward the cancer area. For the phase III component, after successful registration the patient will be randomized to either Arm 1 which consists of a single 16 Gy fraction as image-guided radiosurgery/SBRT or Arm 2 which consists of a single 8 Gy fraction as external beam radiation therapy.Each treatment will last about one hour and will be given in a particular position to help guide the beams of radiation toward the cancer area.
The patient must have localized spine metastasis from the C1 to L5 levels by a screening imaging study [bone scan, PET, CT, or MRI] (a solitary spine metastasis; two separate spine levels; or up to 3 separate sites [e.g., C5, T5-6, and T12] are permitted.) Each of the separate sites may have a maximal involvement of 2 contiguous vertebral bodies. Patients can have other visceral metastasis, and radioresistant tumors (including soft tissue sarcomas, melanomas, and renal cell carcinomas) are eligible. • See Figure 1 below for a depiction of eligible metastatic lesions: 1) a solitary spine metastasis; 2) two contiguous spine levels involved; or 3) a maximum of 3 separate sites. Each of the separate sites may have a maximal involvement of 2 contiguous vertebral bodies. Epidural compression (arrow) is eligible when there is a ≥ 3 mm gap between the spinal cord and the edge of the epidural lesion (see Section 3.1.10). A paraspinal mass ≤ 5 cm is allowed (see Section 3.1.11). • Zubrod Performance Status 0-2; • Age ≥ 18; • History/physical examination within 2 weeks prior to registration; • Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential; • Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control; • MRI of the involved spine within 4 weeks prior to registration to determine the extent of the spine involvement; an MRI is required as it is superior to a CT scan in delineating the spinal cord as well as identifying an epidural or paraspinal soft tissue component. Note: If an MRI was done as a screening imaging study for eligibility (see Section 3.1.1), the MRI can be used as the required MRI for treatment planning. • Numerical Rating Pain Scale within 1 week prior to registration; the patient must have a score on the Scale of ≥ 5 for at least one of the planned sites for spine radiosurgery.Documentation of the patient’s initial pain score is required. Patients taking medication for pain at the time of registration are eligible. • Neurological examination within 1 week prior to registration to rule out rapid neurologic decline; Patients with mild to moderate neurological signs are eligible. These neurological signs include radiculopathy, dermatomal sensory change, and muscle strength of involved extremity 4/5 (lower extremity for ambulation or upper extremity for raising arms and/or arm function). • Patients with epidural compression are eligible provided that there is a ≥ 3 mm gap between the spinal cord and the edge of the epidural lesion. • Patients with a paraspinal mass ≤ 5 cm in the greatest dimension and that is contiguous with spine metastasis are eligible. • Patients must provide study specific informed consent prior to study entry.