Stereotactic Radiotherapy and Image-guided Intensity Modulated Radiotherapy for Spinal Metastatic Tumors

Radiotherapy Clinical Trial

— SCIRSM  

Official title:

Stereotactic Radiotherapy and Conventionally-fractionated-image-guided Intensity Modulated Radiotherapy for Spinal Metastatic Tumors：A Prospective Multicenter Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03963713
• Other study ID #: BYSY-CKIMRT-SPNALM
• Status: Recruiting
• Phase: N/A
• Start date: June 10, 2019
• Est. completion date: May 31, 2022

Study information

• Verified date: May 2019
• Source: Peking University Third Hospital
• Contact: Junjie Wang, MD
• Phone: +860182264910
• Email: junjiewang_edu[@]sina.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Data of 100 patients with spinal metastatic tumor who received stereotactic radiotherapy or conventionally-fractionated image-guided intensity-modulated radiotherapy in the multi-center of the research group from July 2019 to June 2021 will be collected, as well as their follow-up data.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.

Description:

In this study, Data of 100 patients with spinal metastatic tumor who received stereotactic radiotherapy or conventionally-fractionated image-guided intensity-modulated radiotherapy in the multi-center of the research group from July 2019 to June 2021 will be collected, as well as their follow-up data.The metastases were treated with 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).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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 18-80 years old;

• 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 ? type - ? 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:

• Of the anatomy of the spinal metastases form Tomita classification: ?, ? ?, ?.

• 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.

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Radiosurgery
• Radiotherapy
• Spine Metastases

Intervention

Radiation:
• 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.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing
China	The fifth medical center of PLA general hospital	BeiJing	Beijing
China	Third Affiliated Hospital of Guizhou Medical University	GuiYang	Guizhou
China	Mianyang Central Hospital	Mianyang	Sichuan
China	Guangxi ruikang hospital	NanNing	Guangxi
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

Sponsors (10)

Lead Sponsor	Collaborator
Peking University Third Hospital	GEM flower hospital of Liaohe oil field, Guangxi Ruikang Hospital, Hiser Medical Center of Qingdao, Mianyang Central Hospital, Qingdao chengyang hospital, Second Hospital of Shanxi Medical University, Tang-Du Hospital, The fifth medical center of PLA general hospital, Third Affiliated Hospital of Guizhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (12)

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. — View Citation

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 ® spinal bone metastases. J Palliat Med. 2013 Jan;16(1):9-19. doi: 10.1089/jpm.2012.0376. Epub 2012 Nov 20. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cancer pain score	Numerical grading (NRS) should be used for pain intensity assessment, and facial expression pain scoring should be used for patients with difficulty in expression.	1 year after the treatment
Primary	Muscle strength and muscle tension grading	Muscle strength and muscle tension were graded by Numbers	1 year after the treatment
Primary	JOA score of cervical and lumbar vertebrae	JOA score of cervical and lumbar vertebrae	2 years after the treatment
Primary	Quality of Life Score of Tumor Patients(0-60)	Common methods for evaluating the quality of life of patients:The full score of quality of life is 60, the worst is < 20, the worse is 21-30, the average is 31-40, the better is 41-50, and the good is 51-60.	2 years after the treatment
Secondary	Duration of pain response	Time from complete or partial pain relief to pain worsening (= 3 points on the NRPS	1 years after the treatment
Secondary	Overall survival	The time from enrollment to death from any cause	3 years after the treatment
Secondary	Local control rate	The rate at which lesions remained stable during follow-up	3 years after the treatment
Secondary	Adverse reactions	Adverse reactions during and after treatment	6 months after the treatment
Secondary	Progression-free survival	Time from treatment to cancer progression or death	3 years after the treatment