ClinicalTrials.gg
RecruitingNCT06587022ST-SBRTUpdated Sep 19, 2024

Delineation of Target Volume of Stereotactic Radiotherapy for Spinal Tumors

An observational study in Spinal Tumor, sponsored by Peking University Third Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Peking University Third Hospital · Observational

From the registry’s dates

  • Started Jan 2017; still recruiting 9 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
500
Ages
18 Years to 90 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 14 studies in Spinal Cord Neoplasms with a site in China — 7 open to participants now, 7 under way, none of them phase 3. Spinal Cord Neoplasms · China.

Started
2017
the only one that year
Observational
8 of 14
4 open now
Registered
11th of 14
by date
Lead sponsor
4 of 14
Peking University Third Hospital

Among the 14 studies in Spinal Cord Neoplasms with a site in China, this one is the only one that started in 2017, is one of 8 observational ones, and was the 11th registered.

Spinal Cord Neoplasms

105 studies on the registry are indexed under Spinal Cord Neoplasms; 27 are open to participants now.

Browse Spinal Cord Neoplasms studies →

Open to participants now

7 of the 14 studies in Spinal Cord Neoplasms with a site in China are open now. Recruiting first, the newest first:

1 more — sign in →

All 7 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 23 Spinal Cord Neoplasms studies recruiting now, 15 (65%) set no upper age limit and 5 (22%) stop at 75 or younger; 6 take children under 18; 2 take healthy volunteers.

This study: 18 Years to 90 Years · all sexes · no healthy volunteers.

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02

Study summary

The purpose of this study was to compare efficacy and side effects of two target delineation methods for stereotactic radiotherapy of metastatic spinal tumors.

Read the detailed description

The purpose of this study was to compare efficacy and side effects of two target delineation methods for stereotactic radiotherapy of metastatic spinal tumors. This is a bidirectional cohort study planned to enroll approximately 500 patients with metastatic spinal tumors. Patients are divided into two groups according to the target delineation method. Group 1:The target bolume only includes local tumor. Group 2:The target bolume includes local tumor and adjacent vertebral area.

03

Conditions studied

  • Spinal Tumor

Browse trials for

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with malignant tumor spinal metastasis who received or will receive stereotactic radiotherapy, without preoperation.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with spinal or primary tumors receiving stereotactic radiotherapy;
  • Patients with sufficent pre-treatment imaging data
  • Patients who can cooperate with imaging review and follow-up after radiotherapy.

Exclusion criteria

Exclusion Criteria:

  • Patients with an expected survival of less than 3 months;
  • Patients with second-course radiotherapy;
  • Patients with physical conditions that cannot tolerate stereotactic radiotherapy;
  • Patients with extensive spinal and no local therapeutic value
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • group 1

    Group 1(small target delineation):The target bolume only includes local tumor.

    Radiation: Target volume delineation

  • group 2

    Group 2(small target delineation):The target bolume includes local tumor and adjacent vertebral area.

    Radiation: Target volume delineation

Interventions

  • RadiationTarget volume delineation

    Group 1(small target delineation):The target bolume only includes local tumor. Group 2(small target delineation):The target bolume includes local tumor and adjacent vertebral area.

06

What researchers measure

Primary outcomes

  1. Disease Control Rate(DCR)

    Disease Control Rate(DCR),including complete response(CR),partial response(PR) and stable disease(SD ).

    Time frame: 2 years

  2. Pain relief rate

    VAS Score(Visual Analog Scale Score) decreased after treatment

    Time frame: 3 months

Secondary outcomes

  1. Incidence of side effects

    radiation myelitis,radiation esophagitis, etc.

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2017 (actual). Primary completion is estimated for Dec 2026, 119 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 4, 2024
First posted
Sep 19, 2024
StartActual
Jan 1, 2017
Primary completionEst.
Dec 30, 2026
CompletionEst.
Dec 30, 2027
Last update
Sep 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06587022
Responsible party
Sponsor
First posted
Sep 19, 2024
Start date
Jan 1, 2017
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Sep 19, 2024

Study contacts

Hongqing Zhuang, Doctor
Contact
hongqingzhuang@163.com
13051776232
Yuxia Wang
Contact
lily31415926@126.com
15001292991
Hongqing Zhuang
study director · Peking University Third Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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