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RadiotherapySCIRSMNCT03963713

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

A study testing Stereotactic radiotherapy and Conventionally-fractionated image- guided Intensity modulated radiotherapy in people with Radiotherapy and Spine Metastases, run by Peking University Third Hospital at 10 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Radiotherapy, Spine Metastases, Radiosurgery
What is being tested?
Stereotactic radiotherapy and Conventionally-fractionated image- guided Intensity modulated radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
10 sitesChina
Study dates
10 Jun 2019to 31 May 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 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;
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  • 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.

Who cannot join

  • 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;
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  • 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.
  • 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.

Trial locations and contacts

10 sites in 1 country.

Junjie Wang, MD contact

+860182264910

junjiewang_edu@sina.cn

Fei Xu, M Med contact

+8618511866032

xufeibysy@163.com

10 sites in 1 country

China10 sites, 10 recruiting

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100000

    Junjie Wang, MD, +8682264910, junjiewang_edu@sina.cn

    Fei Xu, M Med, +8618511866032, xufeibysy@163.com

    Recruiting

  • The fifth medical center of PLA general hospital

    Beijing, Beijing Municipality, 100000

    XueZhang Duan, M Med

    Recruiting

  • Third Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550000

    Liang Liu, M D, jinshatanwo@163.com

    Recruiting

  • Mianyang Central Hospital

    Mianyang, Sichuan, 621000

    Xiaobo Du, MD, +8613550822229, duxiaobo2005@126.com

    Jie Li, M Med, +8615228324561, lijie.7181@163.com

    Recruiting

  • Guangxi ruikang hospital

    Nanning, Guangxi, 530000

    ZuPing Lian, M Med

    Recruiting

  • GEM flower hospital of Liaohe oil field Tang-Du Hospital

    Panjin, Liaoning, 124010

    Longhai Shen, M Med

    Long hai Shen, M Med

    Recruiting

  • Hiser Medical Center of Qingdao

    Qingdao, Shandong, 266000

    Peng Liu, M Med

    Recruiting

  • Qingdao chengyang people's hospital

    Qingdao, Shandong, 266000

    JanGuo Zhang, M Med

    Recruiting

  • Second hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030000

    Xiang Song, M Med, songxianggeryuan@163.cob

    Lei Zhang, M Med

    Recruiting

  • Tangdu hospital

    Xian, Shanxi, 710000

    DongJie He, M Med

    Recruiting

Other trials in China

About this study

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

Read the detailed 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.

Being tested
Stereotactic radiotherapy, Conventionally-fractionated image- guided Intensity modulated radiotherapy
Keywords
Stereotactic radiotherapy, Intensity modulated radiotherapy, spinal metastatic tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stereotactic radiotherapyRadiation

    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 radiotherapyRadiation

    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.

Study groups in NCT03963713
Study groupRoleWhat they receive
Stereotactic radiotherapyExperimentalIn 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
Receives: Radiation: Stereotactic radiotherapy
Conventionally-fractionated image- guided Intensity modulatedExperimentalIn 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.
Receives: Radiation: Conventionally-fractionated image- guided Intensity modulated radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 year after the treatment

  2. Muscle strength and muscle tension grading

    Muscle strength and muscle tension were graded by Numbers

    Measured: 1 year after the treatment

  3. JOA score of cervical and lumbar vertebrae

    JOA score of cervical and lumbar vertebrae

    Measured: 2 years after the treatment

  4. 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.

    Measured: 2 years after the treatment

Secondary outcomes (5)

  1. Duration of pain response

    Time from complete or partial pain relief to pain worsening (≥ 3 points on the NRPS

    Measured: 1 years after the treatment

  2. Overall survival

    The time from enrollment to death from any cause

    Measured: 3 years after the treatment

  3. Local control rate

    The rate at which lesions remained stable during follow-up

    Measured: 3 years after the treatment

  4. Adverse reactions

    Adverse reactions during and after treatment

    Measured: 6 months after the treatment

  5. Progression-free survival

    Time from treatment to cancer progression or death

    Measured: 3 years after the treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2019
  2. Study start10 Jun 2019
  3. Primary completion31 May 2021 (estimated)
  4. Study completion31 May 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
non-randomized trial
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03963713
Sponsor's protocol ID
BYSY-CKIMRT-SPNALM
Acronym
SCIRSM
Status last verified
May 2019
First submitted
21 May 2019
Last updated
19 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22181327

  • 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.

    PubMed 23816297

  • 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.

    PubMed 15908648

  • 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.

    PubMed 18426607

  • 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.

    PubMed 19250762

  • 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.

    PubMed 28041316

  • 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.

    PubMed 29224900

  • 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.

    PubMed 15537196

  • 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.

    PubMed 17688054

  • 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.

    PubMed 17224814

  • 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.

    PubMed 19092627

  • 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.

    PubMed 23167547

Questions about this trial

What is this clinical trial studying?

A study testing Stereotactic radiotherapy and Conventionally-fractionated image- guided Intensity modulated radiotherapy in people with Radiotherapy and Spine Metastases, run by Peking University Third Hospital at 10 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Junjie Wang, MD (+860182264910, junjiewang_edu@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cancer pain score (time frame: 1 year after the treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03963713, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2019.

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