NSCLCNCT05577052
SBRT Versus Conventional Fractionated Radiotherapy for Vertebral Metastases
A study testing Metastatic vertebrae treated with SBRT in people with NSCLC, run by Wuhan University.
Trial summary
Vertebral metastases are events that affect the quality of life of tumor patients, and are often accompanied by severe pain at the site of metastasis and even by the risk of compression fracture. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- NSCLC
- What is being tested?
- Metastatic vertebrae treated with SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2022to 30 Dec 2024
- 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
- Pathologically confirmed stage IV non-small cell lung cancer.
- General condition score ≤ 2.
- With vertebral metastases combined with painful symptoms.
- Absence of neurological symptoms due to vertebral metastases, such as dyskinesia, defecation or urination abnormalities.
- No previous radiation treatment of any kind to the vertebral body.
- The metastatic vertebra has not been treated surgically
- Vertebral stability score (SINS) ≤ 12
- Patient life expectancy of more than 6 months.
Who cannot join
- Small cell cell lung cancer or large cell carcinoma
- General condition score >2, intolerant of radiotherapy.
- Comorbid neurological symptoms such as dyskinesia, abnormal bowel movements or urination
- Metastatic vertebrae that have received radiotherapy or surgical intervention
- Vertebral stability score (SINS) >12
- Patient life expectancy of less than 6 months
Trial locations and contacts
No sites are listed yet.
About this study
Official title: SBRT Versus Conventional Fractionated Radiotherapy for Vertebral Metastases From Non-small Cell Lung Cancer, an Open, Randomized Phase II Study
Vertebral metastases are events that affect the quality of life of tumor patients, and are often accompanied by severe pain at the site of metastasis and even by the risk of compression fracture. For vertebral metastases who are not yet at risk of vertebral instability fracture, a moderate dose (30Gy/10F) external radiation therapy is the most widely used treatment technique. Previous studies have shown that 60-80% of patients could achieve pain relief with moderate doses of radiation therapy, with median pain control duration of approximately 4 months. Stereotactic Radiation Therapy (SBRT) is currently the most advanced radiation therapy technique. This project proposes to treat vertebral metastases from non-small cell lung cancer using SBRT technology on the True Beam radiotherapy system to compare its efficacy with conventional external irradiation technology in terms of pain relief as well as local control.
Read the detailed description
Vertebral metastases are events that affect the quality of life of tumor patients, and are often accompanied by severe pain at the site of metastasis and even by the risk of compression fracture. For vertebral metastases who are not yet at risk of vertebral instability fracture, a moderate dose (30Gy/10F) external radiation therapy is the most widely used treatment technique. Previous studies have shown that 60-80% of patients could achieve pain relief with moderate doses of radiation therapy, with median pain control duration of approximately 4 months.
Stereotactic Radiation Therapy (SBRT) is currently the most advanced radiation therapy technique. It enables focused radiation therapy with small fields through stereotactic techniques. In June 2021, Zhongnan Hospital of Wuhan University introduced the True Beam radiotherapy system, which has a higher treatment rate compared to conventional radiotherapy equipment, while It is the most reliable vehicle to achieve SBRT.
Therefore, this project proposes to treat vertebral metastases from non-small cell lung cancer using SBRT technology on the True Beam radiotherapy system to compare its efficacy with conventional external irradiation technology in terms of pain relief as well as local control.
- Conditions
- NSCLC
- Being tested
- Metastatic vertebrae treated with SBRT
- Keywords
- SBRT, NSCLC, Vertebral metastasis
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metastatic vertebrae treated with SBRTRadiation
High-dose SBRT treatment
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Metastatic vertebrae treated with SBRT Receives: Radiation: Metastatic vertebrae treated with SBRT |
| Control group | Other | Conventional radiation dose to vertebral metastases Receives: Radiation: Metastatic vertebrae treated with SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete pain relief rate
Complete pain relief rate after completion of radiotherapy
Measured: 3 months
Secondary outcomes (1)
Quality of life scores
Quality of life score after radiotherapy
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start30 Oct 2022 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Conghua Xie,MD,PhD, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577052
- Sponsor's protocol ID
- SBRT for vertebral metastases
- Status last verified
- Oct 2022
- First submitted
- 8 Oct 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SBRT Versus Conventional Fractionated Radiotherapy for Vertebral Metastases From Non-small Cell Lung Cancer, an Open, Randomized Phase II Study
- ClinicalTrials.gov ID
- NCT05577052
- Acronym / sponsor ID
- SBRT for vertebral metastases
- Conditions
- NSCLC
- Keywords
- SBRT, NSCLC, Vertebral metastasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wuhan UniversityUniversity, hospital or other
- Study start
- 30 Oct 2022 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vertebral metastases are events that affect the quality of life of tumor patients, and are often accompanied by severe pain at the site of metastasis and even by the risk of compression fracture. For vertebral metastases who are not yet at risk of vertebral instability fracture, a moderate dose (30Gy/10F) external radiation therapy is the most widely used treatment technique. Previous studies have shown that 60-80% of patients could achieve pain relief with moderate doses of radiation therapy, with median pain control duration of approximately 4 months. Stereotactic Radiation Therapy (SBRT) is currently the most advanced radiation therapy technique. This project proposes to treat vertebral metastases from non-small cell lung cancer using SBRT technology on the True Beam radiotherapy system to compare its efficacy with conventional external irradiation technology in terms of pain relief as well as local control.
Detailed description
Vertebral metastases are events that affect the quality of life of tumor patients, and are often accompanied by severe pain at the site of metastasis and even by the risk of compression fracture. For vertebral metastases who are not yet at risk of vertebral instability fracture, a moderate dose (30Gy/10F) external radiation therapy is the most widely used treatment technique. Previous studies have shown that 60-80% of patients could achieve pain relief with moderate doses of radiation therapy, with median pain control duration of approximately 4 months.
Stereotactic Radiation Therapy (SBRT) is currently the most advanced radiation therapy technique. It enables focused radiation therapy with small fields through stereotactic techniques. In June 2021, Zhongnan Hospital of Wuhan University introduced the True Beam radiotherapy system, which has a higher treatment rate compared to conventional radiotherapy equipment, while It is the most reliable vehicle to achieve SBRT.
Therefore, this project proposes to treat vertebral metastases from non-small cell lung cancer using SBRT technology on the True Beam radiotherapy system to compare its efficacy with conventional external irradiation technology in terms of pain relief as well as local control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Radiation: Metastatic vertebrae treated with SBRTMetastatic vertebrae treated with SBRT |
| Control group | Other | Radiation: Metastatic vertebrae treated with SBRTConventional radiation dose to vertebral metastases |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Pathologically confirmed stage IV non-small cell lung cancer.
- General condition score ≤ 2.
- With vertebral metastases combined with painful symptoms.
- Absence of neurological symptoms due to vertebral metastases, such as dyskinesia, defecation or urination abnormalities.
- No previous radiation treatment of any kind to the vertebral body.
Key exclusion criteria (6 listed)
- Small cell cell lung cancer or large cell carcinoma
- General condition score >2, intolerant of radiotherapy.
- Comorbid neurological symptoms such as dyskinesia, abnormal bowel movements or urination
- Metastatic vertebrae that have received radiotherapy or surgical intervention
- Vertebral stability score (SINS) >12
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metastatic vertebrae treated with SBRTHigh-dose SBRT treatment | Radiation | Control group, Test group |
Primary outcome
Complete pain relief rate
Time frame: 3 months
Complete pain relief rate after completion of radiotherapy
1 secondary outcome
Quality of life scores
Time frame: 3 months and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Individual participant dataSharing planned: Yes
Related trials for NSCLC
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Metastatic vertebrae treated with SBRT in people with NSCLC, run by Wuhan University.
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 8 inclusion and 6 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 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Jing Yu, Dr (02767812539 ext. 86, yujingrt@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete pain relief rate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2022.