Stereotactic Radiotherapy and Image-guided Intensity Modulated Radiotherapy for Spinal Metastatic Tumors
NCT ID: NCT03963713
Last Updated: 2019-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2019-06-10
2022-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Stereotactic radiotherapy
In this study, the metastases were treated with Stereotactic radiotherapy（SBRT）.Using multimodal image fusion to outline the target area.PTV = GTV + 0-10mm Target volume radiation dose: The range of BED value of radiotherapy was 60-72 when the distance between the tumor and gastrointestinal tract or spinal cord was more than 5 mm (alpha/beta=10) and 51.3-59.5 when the distance between the tumor and gastrointestinal tract or spinal cord was less than 5 mm (alpha/beta=10).
Stereotactic radiotherapy
Stereotactic radiotherapy
Using multimodal image fusion to outline the target area.PTV = GTV + 0-10mm Target volume radiation dose: The range of BED value of radiotherapy was 60-72 when the distance between the tumor and gastrointestinal tract or spinal cord was more than 5 mm (alpha/beta=10) and 51.3-59.5 when the distance between the tumor and gastrointestinal tract or spinal cord was less than 5 mm (alpha/beta=10).
Conventionally-fractionated image- guided Intensity modulated
In this study, the metastases were treated with Conventionally-fractionated image- guided Intensity modulated radiotherapy.Using multimodal image fusion to outline the target area.The dose of the target volume radiotherapy dose is 30 Gy/10f or 40Gy/20f.Previous treatment and follow-up data will be analyzed to evaluate the clinical efficacy comparison of stereotactic radiotherapy and conventionally-fractionated image-guided intensity-modulated radiotherapy for spinal metastatic tumors, local control rate and side effects, and to clarify the effectiveness and safety of different doses of radiotherapy.
Conventionally-fractionated image- guided Intensity modulated radiotherapy
Using multimodal image fusion to outline the target area.The dose of the target volume radiotherapy dose is 30 Gy/10f or 40Gy/20f.Previous treatment and follow-up data will be analyzed to evaluate the clinical efficacy comparison of stereotactic radiotherapy and conventionally-fractionated image-guided intensity-modulated radiotherapy for spinal metastatic tumors, local control rate and side effects, and to clarify the effectiveness and safety of different doses of radiotherapy.
Interventions
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Stereotactic radiotherapy
Using multimodal image fusion to outline the target area.PTV = GTV + 0-10mm Target volume radiation dose: The range of BED value of radiotherapy was 60-72 when the distance between the tumor and gastrointestinal tract or spinal cord was more than 5 mm (alpha/beta=10) and 51.3-59.5 when the distance between the tumor and gastrointestinal tract or spinal cord was less than 5 mm (alpha/beta=10).
Conventionally-fractionated image- guided Intensity modulated radiotherapy
Using multimodal image fusion to outline the target area.The dose of the target volume radiotherapy dose is 30 Gy/10f or 40Gy/20f.Previous treatment and follow-up data will be analyzed to evaluate the clinical efficacy comparison of stereotactic radiotherapy and conventionally-fractionated image-guided intensity-modulated radiotherapy for spinal metastatic tumors, local control rate and side effects, and to clarify the effectiveness and safety of different doses of radiotherapy.
Eligibility Criteria
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Inclusion Criteria
* Spine metastatic tumor patients confirmed by pathology and imaging; Number 3; Surgical treatment is not possible due to iatrogenic or (and) personal factors;
* Spinal metastasis after previous systemic treatment or progression after previous treatment of spinal metastasis;
* The anatomy of the spinal metastases form Tomita parting Ⅰ type - Ⅲ type; Without systemic metastasis or metastasis, the lesion was controlled.
* ECOG physical condition score: 0-1, Karnofsky score 60, able to withstand puncture;
* Expected survival 3 months;
* Main organ function is good, without serious hypertension, diabetes and heart disease.
* Has signed informed consent;
* The compliance was good and the family members agreed to follow up for survival.
Exclusion Criteria
* Participated in other drug clinical trials within four weeks; There was a history of bleeding, and any bleeding event with severe grade of CTCAE5.0 or above occurred within 4 weeks before screening;
* Screening of patients with known central nervous system metastasis or a history of central nervous system metastasis. For patients with clinical suspected central nervous system metastasis, CT or MRI examination must be performed within 14 days before randomization to exclude central nervous system metastasis.
* Patients with hypertension who cannot obtain good control by single antihypertensive drug treatment (systolic blood pressure \>140mmHg, diastolic blood pressure \>90mmHg); Having a history of unstable angina pectoris; Patients newly diagnosed with angina within 3 months before screening or myocardial infarction within 6 months before screening; Arrhythmia (including QTcF: 450ms in male and 470ms in female) requires long-term use of anti-arrhythmia drugs and New York heart association grade II cardiac dysfunction;
* Long-term unhealed wounds or incomplete fracture healing;
* Imaging showed that the tumor had invaded important blood vessels or the researchers judged that the patient's tumor had a very high possibility to invade important blood vessels during the treatment and cause fatal bleeding;
* Coagulation function is unusual, have haemorrhage tendency person (before random 14 days must satisfy: below the circumstance that does not use anticoagulant INR is in normal value range); Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; The use of low-dose warfarin (1mg oral, once daily) or low-dose aspirin (no more than 100mg daily) for preventive purposes is permitted on the premise that the international standardized ratio of prothrombin time (INR) is 1.5;
* Screening for the occurrence of hyperactive/venous thrombosis events in the first 6 months, such as cerebrovascular accidents (including temporary ischemic attack), deep vein thrombosis (except for venous thrombosis caused by intravenous catheterization in the early stage of chemotherapy, which was determined by the researchers to have recovered) and pulmonary embolism, etc.
* Thyroid function was abnormal in the past and could not be kept within the normal range even in the case of drug treatment.
(10) Attending has a history of psychotropic drug abuse, and can't attend or has mental disorder;
* Always half a year after spinal tumors or other close to the spine tumor lesion lesions radiation;
* Immunodeficiency disease, or has other acquired, congenital immunodeficiency disease, or has a history of organ transplantation;
* Judgment according to the researchers, there is serious to endanger the safety of patients or patients completed the research associated with disease.
18 Years
80 Years
ALL
No
Sponsors
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Mianyang Central Hospital
OTHER
Second Hospital of Shanxi Medical University
OTHER
Qingdao chengyang hospital
UNKNOWN
Qingdao Hiser Medical Group
OTHER
Beijing 302 Hospital
OTHER
Guangxi Ruikang Hospital
OTHER
Third Affiliated Hospital of Guizhou Medical University
UNKNOWN
Panjin Liaohe Oilfield Gem Flower Hospital
OTHER
Tang-Du Hospital
OTHER
Peking University Third Hospital
OTHER
Responsible Party
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Principal Investigators
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Junjie Wang, MD
Role: STUDY_CHAIR
Peking University Third Hospital
Fei Xu, M Med
Role: STUDY_DIRECTOR
Peking University Third Hospital
Hongqing Zhuang, M Med
Role: PRINCIPAL_INVESTIGATOR
Peking University Third Hospital
Xiaobo Du, MD
Role: PRINCIPAL_INVESTIGATOR
Mianyang Central Hospital
Jie Li, M Med
Role: PRINCIPAL_INVESTIGATOR
Mianyang Central Hospital
Xiang Song, M Med
Role: PRINCIPAL_INVESTIGATOR
Second Hospital of Shanxi Medical University
Lei Zhang, M Med
Role: PRINCIPAL_INVESTIGATOR
Second Hospital of Shanxi Medical University
Jianguo Zhang, M Med
Role: PRINCIPAL_INVESTIGATOR
Qingdao chengyang people's hospital
Peng Liu, M Med
Role: PRINCIPAL_INVESTIGATOR
Qingdao Hiser Medical Group
Xuezhang Duan, MD
Role: PRINCIPAL_INVESTIGATOR
Beijing 302 Hospital
Zuping Lian, MD
Role: PRINCIPAL_INVESTIGATOR
Guangxi Ruikang Hospital
Liang Liu, MD
Role: PRINCIPAL_INVESTIGATOR
Third Affiliated Hospital of Guizhou Medical University
Longhai Shen, M Med
Role: PRINCIPAL_INVESTIGATOR
Panjin Liaohe Oilfield Gem Flower Hospital
Dongjie He, M Med
Role: PRINCIPAL_INVESTIGATOR
Tang-Du Hospital
Xuemin Li, MD
Role: PRINCIPAL_INVESTIGATOR
Peking University Third Hospital
Yi Chen, MD
Role: PRINCIPAL_INVESTIGATOR
Peking University Third Hospital
Locations
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Peking University Third Hospital
Beijing, Beijing Municipality, China
The fifth medical center of PLA general hospital
Beijing, Beijing Municipality, China
Guangxi ruikang hospital
Nanning, Guangxi, China
Third Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
GEM flower hospital of Liaohe oil field Tang-Du Hospital
Panjin, Liaoning, China
Hiser Medical Center of Qingdao
Qingdao, Shandong, China
Qingdao chengyang people's hospital
Qingdao, Shandong, China
Second hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Tangdu hospital
Xian, Shanxi, China
Mianyang Central Hospital
Mianyang, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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XueZhang Duan, M Med
Role: primary
ZuPing Lian, M Med
Role: primary
Longhai Shen, M Med
Role: primary
Peng Liu, M Med
Role: primary
JanGuo Zhang, M Med
Role: primary
DongJie He, M Med
Role: primary
References
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Massicotte E, Foote M, Reddy R, Sahgal A. Minimal access spine surgery (MASS) for decompression and stabilization performed as an out-patient procedure for metastatic spinal tumours followed by spine stereotactic body radiotherapy (SBRT): first report of technique and preliminary outcomes. Technol Cancer Res Treat. 2012 Feb;11(1):15-25. doi: 10.7785/tcrt.2012.500230.
Sahgal A, Whyne CM, Ma L, Larson DA, Fehlings MG. Vertebral compression fracture after stereotactic body radiotherapy for spinal metastases. Lancet Oncol. 2013 Jul;14(8):e310-20. doi: 10.1016/S1470-2045(13)70101-3.
Rades D, Stalpers LJ, Veninga T, Schulte R, Hoskin PJ, Obralic N, Bajrovic A, Rudat V, Schwarz R, Hulshof MC, Poortmans P, Schild SE. Evaluation of five radiation schedules and prognostic factors for metastatic spinal cord compression. J Clin Oncol. 2005 May 20;23(15):3366-75. doi: 10.1200/JCO.2005.04.754.
Gong Y, Wang J, Bai S, Jiang X, Xu F. Conventionally-fractionated image-guided intensity modulated radiotherapy (IG-IMRT): a safe and effective treatment for cancer spinal metastasis. Radiat Oncol. 2008 Apr 22;3:11. doi: 10.1186/1748-717X-3-11.
Guckenberger M, Goebel J, Wilbert J, Baier K, Richter A, Sweeney RA, Bratengeier K, Flentje M. Clinical outcome of dose-escalated image-guided radiotherapy for spinal metastases. Int J Radiat Oncol Biol Phys. 2009 Nov 1;75(3):828-35. doi: 10.1016/j.ijrobp.2008.11.017. Epub 2009 Feb 26.
Zhang M, Chen YR, Chang SD, Veeravagu A. CyberKnife stereotactic radiosurgery for the treatment of symptomatic vertebral hemangiomas: a single-institution experience. Neurosurg Focus. 2017 Jan;42(1):E13. doi: 10.3171/2016.9.FOCUS16372.
Gandhidasan S, Ball D, Kron T, Bressel M, Shaw M, Chu J, Chander S, Wheeler G, Plumridge N, Chesson B, David S, Siva S. Single Fraction Stereotactic Ablative Body Radiotherapy for Oligometastasis: Outcomes from 132 Consecutive Patients. Clin Oncol (R Coll Radiol). 2018 Mar;30(3):178-184. doi: 10.1016/j.clon.2017.11.010. Epub 2017 Dec 8.
Ryu S, Rock J, Rosenblum M, Kim JH. Patterns of failure after single-dose radiosurgery for spinal metastasis. J Neurosurg. 2004 Nov;101 Suppl 3:402-5.
Chang EL, Shiu AS, Mendel E, Mathews LA, Mahajan A, Allen PK, Weinberg JS, Brown BW, Wang XS, Woo SY, Cleeland C, Maor MH, Rhines LD. Phase I/II study of stereotactic body radiotherapy for spinal metastasis and its pattern of failure. J Neurosurg Spine. 2007 Aug;7(2):151-60. doi: 10.3171/SPI-07/08/151.
Gerszten PC, Burton SA, Ozhasoglu C, Welch WC. Radiosurgery for spinal metastases: clinical experience in 500 cases from a single institution. Spine (Phila Pa 1976). 2007 Jan 15;32(2):193-9. doi: 10.1097/01.brs.0000251863.76595.a2.
Wowra B, Zausinger S, Drexler C, Kufeld M, Muacevic A, Staehler M, Tonn JC. CyberKnife radiosurgery for malignant spinal tumors: characterization of well-suited patients. Spine (Phila Pa 1976). 2008 Dec 15;33(26):2929-34. doi: 10.1097/BRS.0b013e31818c680a.
Expert Panel on Radiation Oncology-Bone Metastases; Lo SS, Lutz ST, Chang EL, Galanopoulos N, Howell DD, Kim EY, Konski AA, Pandit-Taskar ND, Rose PS, Ryu S, Silverman LN, Sloan AE, Van Poznak C. ACR Appropriateness Criteria (R) spinal bone metastases. J Palliat Med. 2013 Jan;16(1):9-19. doi: 10.1089/jpm.2012.0376. Epub 2012 Nov 20.
Other Identifiers
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BYSY-CKIMRT-SPNALM
Identifier Type: -
Identifier Source: org_study_id
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