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

Last updated: July 18, 2019
Sponsor: Peking University Third Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cancer Treatment

Neoplasm Metastasis

Cancer

Treatment

N/A

Clinical Study ID

NCT03963713
BYSY-CKIMRT-SPNALM
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18-80 years old;

  • Spine metastatic tumor patients confirmed by pathology and imaging; Number 3; Surgicaltreatment is not possible due to iatrogenic or (and) personal factors;

  • Spinal metastasis after previous systemic treatment or progression after previoustreatment of spinal metastasis;

  • The anatomy of the spinal metastases form Tomita parting Ⅰ type - Ⅲ type; Withoutsystemic 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

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 ofbleeding, and any bleeding event with severe grade of CTCAE5.0 or above occurredwithin 4 weeks before screening;

  • Screening of patients with known central nervous system metastasis or a history ofcentral nervous system metastasis. For patients with clinical suspected centralnervous system metastasis, CT or MRI examination must be performed within 14 daysbefore randomization to exclude central nervous system metastasis.

  • Patients with hypertension who cannot obtain good control by single antihypertensivedrug treatment (systolic blood pressure >140mmHg, diastolic blood pressure >90mmHg);Having a history of unstable angina pectoris; Patients newly diagnosed with anginawithin 3 months before screening or myocardial infarction within 6 months beforescreening; Arrhythmia (including QTcF: 450ms in male and 470ms in female) requireslong-term use of anti-arrhythmia drugs and New York heart association grade II cardiacdysfunction;

  • Long-term unhealed wounds or incomplete fracture healing;

  • Imaging showed that the tumor had invaded important blood vessels or the researchersjudged that the patient's tumor had a very high possibility to invade important bloodvessels during the treatment and cause fatal bleeding;

  • Coagulation function is unusual, have haemorrhage tendency person (before random 14days must satisfy: below the circumstance that does not use anticoagulant INR is innormal value range); Patients treated with anticoagulants or vitamin K antagonistssuch 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 ispermitted 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 6months, such as cerebrovascular accidents (including temporary ischemic attack), deepvein thrombosis (except for venous thrombosis caused by intravenous catheterization inthe early stage of chemotherapy, which was determined by the researchers to haverecovered) and pulmonary embolism, etc.

  • Thyroid function was abnormal in the past and could not be kept within the normalrange even in the case of drug treatment.

(10) Attending has a history of psychotropic drug abuse, and can't attend or hasmental disorder;

  • Always half a year after spinal tumors or other close to the spine tumor lesionlesions 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 ofpatients or patients completed the research associated with disease.

Study Design

Total Participants: 100
Study Start date:
June 10, 2019
Estimated Completion Date:
May 31, 2022

Study 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.

Connect with a study center

  • The fifth medical center of PLA general hospital

    BeiJing, Beijing 100000
    China

    Active - Recruiting

  • Peking University Third Hospital

    Beijing, Beijing 100000
    China

    Active - Recruiting

  • Guangxi ruikang hospital

    NanNing, Guangxi 530000
    China

    Active - Recruiting

  • Third Affiliated Hospital of Guizhou Medical University

    GuiYang, Guizhou 550000
    China

    Active - Recruiting

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

    Panjin, Liaoning 124010
    China

    Active - Recruiting

  • Hiser Medical Center of Qingdao

    Qingdao, Shandong 266000
    China

    Active - Recruiting

  • Qingdao chengyang people's hospital

    Qingdao, Shandong 266000
    China

    Active - Recruiting

  • Second hospital of Shanxi Medical University

    TaiYuan, Shanxi 030000
    China

    Active - Recruiting

  • Tangdu hospital

    Xian, Shanxi 710000
    China

    Active - Recruiting

  • Mianyang Central Hospital

    Mianyang, Sichuan 621000
    China

    Active - Recruiting

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