Image-Guided Radiosurgery or Stereotactic Body Radiation Therapy in Treating Patients With Localized Spine Metastasis
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|ClinicalTrials.gov Identifier: NCT00922974|
Recruitment Status : Completed
First Posted : June 18, 2009
Results First Posted : May 16, 2019
Last Update Posted : April 29, 2020
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This randomized phase II/III trial is studying how well image-guided radiosurgery or stereotactic body radiation therapy works and compares it to external-beam radiation therapy in treating patients with localized spine metastasis.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Cancer Pain||Radiation: External beam radiation therapy Radiation: Radiosurgery/SBRT||Phase 2 Phase 3|
- Determine the feasibility of successfully delivering image-guided radiosurgery or stereotactic body radiotherapy (SBRT) in patients with spine metastases in a cooperative group setting. (Phase II)
- Determine whether image-guided radiosurgery or SBRT (single dose of 16 Gy) improves pain control as measured by the 11-point Numerical Rating Pain Scale (NRPS) compared to conventional external beam radiotherapy (single dose of 8 Gy). (Phase III)
- Determine whether image-guided radiosurgery or SBRT improves the rapidity of pain response and increases the duration of pain response at the treated site(s) compared to conventional external beam radiotherapy, as measured by the NRPS. (Phase III)
- Compare adverse events associated with these treatment regimens, as measured by NCI CTCAE v3.0 criteria. (Phase III)
- Evaluate the long-term effects (24 months) of image-guided radiosurgery or SBRT on the vertebral bone (e.g., compression fracture) and the spinal cord, as measured by MRI. (Phase III)
This is a multicenter, phase II study followed by a randomized phase III study. Patients enrolled in the phase III portion are stratified according to the number of spine metastases to be treated (1 vs 2-3) and the type of tumor (radioresistant [including soft tissue sarcomas, melanomas, and renal cell carcinomas] vs other).
Phase II patients undergo MRI of the treated spine at baseline and at 3 months; phase III patients undergo MRI at baseline and at 3, 6, 12, and 24 months. Patients enrolled in the phase III portion also complete the Numerical Rating Pain Scale at baseline, at 1, 2, and 3 weeks after randomization, and at 1, 3, 6, 12, and 24 months. Patients are followed after completion of study treatment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||399 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis|
|Actual Study Start Date :||November 2009|
|Actual Primary Completion Date :||January 2018|
|Actual Study Completion Date :||April 6, 2020|
Single fraction dose image-guided radiosurgery / stereotactic body radiotherapy (SBRT). The phase II component uses 16 Gy. The phase III component allows 16 or 18 Gy as preferred by the treating physician.
|Active Comparator: External Beam Radiation Therapy||
Radiation: External beam radiation therapy
Single fraction dose of 8 Gy external beam radiation therapy
Other Name: EBRT
- Percentage of Patients Receiving Radiosurgery/SBRT Per Protocol or With Minor Variation (Phase II) [ Time Frame: The day of protocol treatment ]
Treatment delivery was centrally reviewed by the study chair and medical physics co-chair. Success was defined as having a review of "per protocol" or "minor variation". A 70% success rate was required for continuation to the phase III component.
Target volume compliance in is defined as the following levels of target coverage in reference to dose volume:
- Per protocol: ≥ 90%
- Minor variation: 80%-90%
- Major deviation: <80% of of dose volume.
Image-Guided Radiotherapy (IGRT) compliance is defined as the following differences in IGRT images between simulation/planning and treatment, as well as at the end of treatment:
- Per protocol: <2 mm
- Minor variation: 2mm - 3mm
- Major deviation: > 3mm
- Percentage of Patients With Complete or Partial Pain Response at 3 Months (Phase III) [ Time Frame: Baseline and 3 months ]
Pain is measured by the Numerical Rating Pain Scale (NRPS) a numerical 11-point scale (0-10) with 0 = no pain, 1-4 = mild, 5-6 = moderate, and 7-10 = severe with 10 the worst pain imaginable. Pain response is calculated as 3 month score - baseline score with a positive value indicating increased pain and a negative value indicating decreased pain. Patients with complete or partial pain response as defined below are considered responders. The index site is the lesion with the highest baseline (day of radiosurgery) pain score. If multiple sites have the same baseline pain score, the index site is the most cephalad lesion.
- Complete response: post-treatment pain score of 0 at the index site, no increase in narcotic pain medication, and no increase in pain score at the secondary treated site(s).
- Partial response: post-treatment improvement of at least 3 points at the index site, no increase in narcotic pain medication, and no increase in pain score at the secondary treated site(s).
- Median Time to Pain Response (Phase III) [ Time Frame: Baseline to 24 months ]
- Median Duration of Pain Response (Phase III) [ Time Frame: Baseline to 24 months ]
- Percentage of Patients With Adverse Events at 3 Months (Phase III) [ Time Frame: Baseline to 3 months ]Adverse events (AE) were collected using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
- Long-term Effects (24 Months) of Treatment on the Vertebral Bone (e.g., Compression Fracture) and Spinal Cord (Phase III) [ Time Frame: Baseline, 3, 12, and 24 months ]
- Change in Functional Assessment of Cancer Therapy - General (FACT-G) Total Score at 3 Months (Phase III) [ Time Frame: Baseline and 3 months ]The FACT-G is a validated 27-item measure in which a higher score represents higher quality of life (QOL). Physical, functional, social and emotional well-being subscale scores are added together to form the FACT-G total score. Responses range from 0=Not a lot to 4=Very much. Certain items must be reversed before being added, by subtracting the response from 4. Subscale items are added together, multiplied by the number of items in the subscale, then divided by the number of items answered to obtain subscale totals. Total score ranges from 0-108; physical, social and functional subscales from 0-28; emotional subscale from 0-24. Each subscale requires at least 50% of the items to be completed while the overall response rate must be greater than 80%. If items are missing the subscale scores can be prorated. Change at 3 months is calculated as 3 month score - baseline score with a positive change indicating improvement in QOL.
- The Change Trend in the Brief Pain Inventory (BPI) Score Over 24 Months [ Time Frame: Baseline, 3, 12, and 24 months ]
- The Change Trend in the EuroQol- 5 Dimension (EQ-5D) Score Over 24 Months [ Time Frame: Baseline, 3, 12, and 24 months ]
- The Change Trend in the Functional Assessment of Cancer Therapy - General (FACT-G) Score Over 24 Months [ Time Frame: Baseline, 3, 12, and 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00922974
|Principal Investigator:||Samuel Ryu, MD||Josephine Ford Cancer Center|