deltatrials
Unknown NA INTERVENTIONAL 2-arm NCT03963713

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

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

Sponsor: Beijing 302 Hospital

Updated 10 times since 2019 Last updated: Jul 18, 2019 Started: Jun 10, 2019 Primary completion: May 31, 2021 Completion: May 31, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03963713, this NA trial focuses on Radiosurgery and Radiotherapy and remains ongoing. Sponsored by Beijing 302 Hospital, it has been updated 10 times since 2019, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

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.

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.

Status Flow

~Jun 2019 – ~Aug 2019 · 2 months · monthly snapshotNot Yet Recruiting~Aug 2019 – ~Jan 2021 · 17 months · monthly snapshotRecruiting~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshotRecruiting~Feb 2021 – ~Oct 2021 · 8 months · monthly snapshotRecruiting~Oct 2021 – ~Jul 2022 · 9 months · monthly snapshotRecruiting~Jul 2022 – ~Jul 2024 · 24 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotUnknown~Sep 2025 – present · 7 months · monthly snapshotUnknown~Jan 2026 – present · 3 months · monthly snapshotUnknown

Change History

10 versions recorded
  1. Jan 2026 — Present [monthly]

    Unknown NA

  2. Sep 2025 — Present [monthly]

    Unknown NA

  3. Sep 2024 — Sep 2025 [monthly]

    Unknown NA

  4. Jul 2024 — Sep 2024 [monthly]

    Unknown NA

    Status: Unknown StatusUnknown

  5. Jul 2022 — Jul 2024 [monthly]

    Unknown Status NA

    Status: RecruitingUnknown Status

Show 5 earlier versions
  1. Oct 2021 — Jul 2022 [monthly]

    Recruiting NA

  2. Feb 2021 — Oct 2021 [monthly]

    Recruiting NA

  3. Jan 2021 — Feb 2021 [monthly]

    Recruiting NA

  4. Aug 2019 — Jan 2021 [monthly]

    Recruiting NA

    Status: Not Yet RecruitingRecruiting

  5. Jun 2019 — Aug 2019 [monthly]

    Not Yet Recruiting NA

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

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

For direct contact, visit the study record on ClinicalTrials.gov .