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

Not Applicable

• Conditions: Radiosurgery; Spine Metastases; Radiotherapy
• Interventions: Radiation: Stereotactic radiotherapy; Radiation: Conventionally-fractionated image- guided Intensity modulated radiotherapy

• Registration Number: NCT03963713
• Lead Sponsor: Peking University Third Hospital

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.

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.

Study Timeline

• Status Verified: 2019-05
• Study First Submitted: 2019-05-21
• Study First Submitted QC: 2019-05-23
• Study First Posted: 2019-05-28
• Study Start: 2019-06-10
• Last Update Submitted: 2019-07-18
• Last Update Posted: 2019-07-19
• Primary Completion: 2021-05-31
• Study Completion: 2022-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 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.

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stereotactic radiotherapy	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
Conventionally-fractionated image- guided Intensity modulated	Conventionally-fractionated image- guided Intensity modulated radiotherapy	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.

Primary Outcome Measures

Name	Time	Method
Cancer pain score	1 year after the treatment	Numerical grading (NRS) should be used for pain intensity assessment, and facial expression pain scoring should be used for patients with difficulty in expression.
Muscle strength and muscle tension grading	1 year after the treatment	Muscle strength and muscle tension were graded by Numbers
JOA score of cervical and lumbar vertebrae	2 years after the treatment	JOA score of cervical and lumbar vertebrae
Quality of Life Score of Tumor Patients(0-60)	2 years after the treatment	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.

Secondary Outcome Measures

Name	Time	Method
Duration of pain response	1 years after the treatment	Time from complete or partial pain relief to pain worsening (≥ 3 points on the NRPS
Local control rate	3 years after the treatment	The rate at which lesions remained stable during follow-up
Adverse reactions	6 months after the treatment	Adverse reactions during and after treatment
Progression-free survival	3 years after the treatment	Time from treatment to cancer progression or death
Overall survival	3 years after the treatment	The time from enrollment to death from any cause

Trial Locations

Locations (10)

The fifth medical center of PLA general hospital; 🇨🇳 BeiJing, Beijing, China

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, 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

Mianyang Central Hospital; 🇨🇳 Mianyang, Sichuan, China

Tangdu hospital; 🇨🇳 Xian, Shanxi, China