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

NCT03963713 | Unknown

• 1 other identifier: BYSY-CKIMRT-SPNALM
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Radiotherapy; Spine Metastases; Radiosurgery

Keywords

Stereotactic radiotherapy; Intensity modulated radiotherapy; spinal metastatic tumors

Outcome Measures

Primary Outcomes (4)

• 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

• Muscle strength and muscle tension grading

  Muscle strength and muscle tension were graded by Numbers

  1 year after the treatment

• JOA score of cervical and lumbar vertebrae

  JOA score of cervical and lumbar vertebrae

  2 years after the treatment

• 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 Outcomes (5)

• Duration of pain response

  1 years after the treatment

• Overall survival

  3 years after the treatment

• Local control rate

  3 years after the treatment

• Adverse reactions

  6 months after the treatment

• Progression-free survival

  3 years after the treatment

Study Arms (2)

Stereotactic radiotherapy

EXPERIMENTAL

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

Radiation: Stereotactic radiotherapy

Conventionally-fractionated image- guided Intensity modulated

EXPERIMENTAL

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.

Radiation: Conventionally-fractionated image- guided Intensity modulated radiotherapy

Interventions

Stereotactic radiotherapy RADIATION

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

Conventionally-fractionated image- guided Intensity modulated radiotherapy RADIATION

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• Of the anatomy of the spinal metastases form Tomita classification: Ⅳ, Ⅴ Ⅵ, Ⅶ.
• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Mianyang Central Hospital: collaborator
• Second Hospital of Shanxi Medical University: collaborator
• Qingdao chengyang hospital: collaborator
• Qingdao Hiser Medical Group: collaborator
• Beijing 302 Hospital: collaborator
• Guangxi Ruikang Hospital: collaborator
• Third Affiliated Hospital of Guizhou Medical University: collaborator
• Panjin Liaohe Oilfield Gem Flower Hospital: collaborator
• Tang-Du Hospital: collaborator

Study Sites (10)

Peking University Third Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

The fifth medical center of PLA general hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Guangxi ruikang hospital

Nanning, Guangxi, 530000, China

RECRUITING

Third Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, 550000, China

RECRUITING

GEM flower hospital of Liaohe oil field Tang-Du Hospital

Panjin, Liaoning, 124010, China

RECRUITING

Hiser Medical Center of Qingdao

Qingdao, Shandong, 266000, China

RECRUITING

Qingdao chengyang people's hospital

Qingdao, Shandong, 266000, China

RECRUITING

Second hospital of Shanxi Medical University

Taiyuan, Shanxi, 030000, China

RECRUITING

Tangdu hospital

Xian, Shanxi, 710000, China

RECRUITING

Mianyang Central Hospital

Mianyang, Sichuan, 621000, China

RECRUITING

Related Publications (12)

• 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.

  PMID: 22181327 BACKGROUND

• 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.

  PMID: 23816297 BACKGROUND

• 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.

  PMID: 15908648 BACKGROUND

• 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.

  PMID: 18426607 BACKGROUND

• 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.

  PMID: 19250762 BACKGROUND

• 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.

  PMID: 28041316 BACKGROUND

• 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.

  PMID: 29224900 BACKGROUND

• 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.

  PMID: 15537196 BACKGROUND

• 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.

  PMID: 17688054 BACKGROUND

• 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.

  PMID: 17224814 BACKGROUND

• 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.

  PMID: 19092627 BACKGROUND

• 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.

  PMID: 23167547 BACKGROUND

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Junjie Wang, MD

  Peking University Third Hospital

  STUDY CHAIR

• Fei Xu, M Med

  Peking University Third Hospital

  STUDY DIRECTOR

• Hongqing Zhuang, M Med

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

• Xiaobo Du, MD

  Mianyang Central Hospital

  PRINCIPAL INVESTIGATOR

• Jie Li, M Med

  Mianyang Central Hospital

  PRINCIPAL INVESTIGATOR

• Xiang Song, M Med

  Second Hospital of Shanxi Medical University

  PRINCIPAL INVESTIGATOR

• Lei Zhang, M Med

  Second Hospital of Shanxi Medical University

  PRINCIPAL INVESTIGATOR

• Jianguo Zhang, M Med

  Qingdao chengyang people's hospital

  PRINCIPAL INVESTIGATOR

• Peng Liu, M Med

  Qingdao Hiser Medical Group

  PRINCIPAL INVESTIGATOR

• Xuezhang Duan, MD

  Beijing 302 Hospital

  PRINCIPAL INVESTIGATOR

• Zuping Lian, MD

  Guangxi Ruikang Hospital

  PRINCIPAL INVESTIGATOR

• Liang Liu, MD

  Third Affiliated Hospital of Guizhou Medical University

  PRINCIPAL INVESTIGATOR

• Longhai Shen, M Med

  Panjin Liaohe Oilfield Gem Flower Hospital

  PRINCIPAL INVESTIGATOR

• Dongjie He, M Med

  Tang-Du Hospital

  PRINCIPAL INVESTIGATOR

• Xuemin Li, MD

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

• Yi Chen, MD

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junjie Wang, MD

CONTACT

+860182264910; junjiewang_edu@sina.cn

Fei Xu, M Med

CONTACT

+8618511866032; xufeibysy@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: non-randomized trial

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: May 28, 2019
• Study Start: June 10, 2019
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2022
• Last Updated: July 19, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (10)