PainNCT02972229
Whole Versus Partial Vertebral Body IMRT for Spinal Metastases
A study testing 10x(3-5) Gy IMRT and 10x3 Gy IMRT in people with Pain, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Trial summary
To compare the treatment effect and toxicity between Intensity-Modulated Radiation therapy for whole metastatic vertebral body and simple metastatic lesions of vertebra in metastatic spinal tumors Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain
- What is being tested?
- 10x(3-5) Gy IMRT and 10x3 Gy IMRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Nov 2019
- 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
- Patients with a histologically confirmed tumor diagnosis, with secondary -diagnosed solitary/multiple spinal bone metastases
- Indication for RT of the spinal bone metastases
- Maximal two irradiated vertebral-bodies per region
- Maximal two different vertebral regions
- Age: between 18 and 80 years
- Karnofsky index (10) ≥ 70
- Signed Declaration of Informed Consent
- Tumor distance > 3 mm to myelon
Who cannot join
- Multiple myeloma or lymphoma
- Significant neurological or psychiatric disorders, including dementia and epileptic seizures
- Earlier RT at the current irradiated site
- Other severe disorders that in the judgement of the study director may prevent the patient's participation in the study
- Lacking or diminished legal capacity
- Any medical of psychological condition that the study director considers a preventive factor for the patient's ability to complete the study or to adequately
- understand the scope of the study and to give his/her consent
About this study
To compare the treatment effect and toxicity between Intensity-Modulated Radiation therapy for whole metastatic vertebral body and simple metastatic lesions of vertebra in metastatic spinal tumors
Read the detailed description
This study is a prospective, randomized, single center, controlled explorative study in the parallel-group design to evaluate the difference in clinical outcomes for patients with metastatic spine disease treated with a whole versus partial vertebral body contouring approach. Thereby two different techniques were evaluated: whole vertebral body (WB) group with 10 x 3Gy or partial vertebral body (PB) group with 10x (3-5)Gy. Prior to their enrolment into the study, the patients will undergo a staging of the vertebral column in connection with their radiation-planning computed tomography (CT) and MRI to measure the myelon dimension. After the baseline results have been recorded, the patients will be randomized into one of the two groups: PB group RT 10x (3-5) Gy (n = 30) or WB group RT 10 x 3 Gy (n = 30). The target parameters will be measured and recorded at baseline, at 1 to 2 weeks; and at months 2 to 3, 4 to 6 and 7 to 12 after treatment.
The primary endpoint was the time to pain relief. Secondary endpoints were quality of life (QoL), fatigue, pain, overall survival, bone survival, local control, pathological fracture, pain-free internal and neurological deficit. The baseline examination shall be carried out on the first day of radiotherapy prior to the start of therapy and is scheduled to comprise the comprehensive recording of the sociodemographic data, the recording of the current pain situation, the quality of life, and the current degree of fatigue. The follow-up examinations shall take place at each follow up visit , measuring those parameters recorded at the baseline examination. The further follow-up examinations shall correspond to those carried out as standard after-care investigations.
The secondary endpoints such as fatigue and quality of life shall be recorded using validated questionnaires (EORTC QLQ FA13 and EORTC QLQ BM22. All patients will also be asked to record their pain history using a pain diary (documentation of medication daily during treatment, once weekly after the end of treatment, VAS pain scale). Furthermore, the local control was assessed by means of CT images taken prior to, three and six months after RT. The pain response was documented on the VAS (range 0-10). Complete response (CR) was defined as VAS = 0 after three and six months, partial response (PR) as an improvement by at least two score points after three and six months. Overall survival (OS) was defined as time from initial diagnosis until death, bone survival as time from initial diagnosis of spinal bone metastasis until death.
In each case, the treatment plan was designed based on tumor geometry, proximity to the spinal cord, and location. The planning tumor volume (PTV) was defined as equal to gross tumor volume (GTV). The spinal cord, cauda equina, nerve roots, and bowel were contoured as organs at risk (OARs) and critical structures. An inverse treatment planning method along with a linear optimization algorithm were employed. The target volume was designated to include either the GTV and the entire vertebral body (WB group) or only the GTV (PB group) at each spinal level.
- Conditions
- Pain
- Being tested
- 10x(3-5) Gy IMRT, 10x3 Gy IMRT
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10x(3-5) Gy IMRTRadiation
10x(3-5) Gy IMRT on partial vertebral body for spinal metastases
10x3 Gy IMRTRadiation
10x3 Gy IMRT on whole vertebral body for spinal metastases
| Study group | Role | What they receive |
|---|---|---|
| partial body group | Experimental | 10x(3-5) Gy IMRT on partial vertebral body Receives: Radiation: 10x(3-5) Gy IMRT |
| whole body group | Active comparator | 10x3 Gy IMRT on whole vertebral body Receives: Radiation: 10x3 Gy IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
the time to pain relief
Measured: 3 months after treatment
Secondary outcomes (3)
quality of life measured on an EORTC BM22 questionnaire
Measured: 3 and 6 months after therapy completed
Overall survival
Measured: 1 year
local control
local control as bone density is assessed 12 weeks post completion of radiotherapy using follow-up CT scan of the spine
Measured: 3 months after therapy completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionOct 2018 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhenwei Zou, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02972229
- Sponsor's protocol ID
- WuhanUH201610
- Status last verified
- Nov 2016
- First submitted
- 16 Nov 2016
- Last updated
- 23 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Versus Partial Vertebral Body IMRT for Spinal Metastases
- ClinicalTrials.gov ID
- NCT02972229
- Acronym / sponsor ID
- WuhanUH201610
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 23 Nov 2016 (estimated)
- 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.
To compare the treatment effect and toxicity between Intensity-Modulated Radiation therapy for whole metastatic vertebral body and simple metastatic lesions of vertebra in metastatic spinal tumors
Detailed description
This study is a prospective, randomized, single center, controlled explorative study in the parallel-group design to evaluate the difference in clinical outcomes for patients with metastatic spine disease treated with a whole versus partial vertebral body contouring approach. Thereby two different techniques were evaluated: whole vertebral body (WB) group with 10 x 3Gy or partial vertebral body (PB) group with 10x (3-5)Gy. Prior to their enrolment into the study, the patients will undergo a staging of the vertebral column in connection with their radiation-planning computed tomography (CT) and MRI to measure the myelon dimension. After the baseline results have been recorded, the patients will be randomized into one of the two groups: PB group RT 10x (3-5) Gy (n = 30) or WB group RT 10 x 3 Gy (n = 30). The target parameters will be measured and recorded at baseline, at 1 to 2 weeks; and at months 2 to 3, 4 to 6 and 7 to 12 after treatment.
The primary endpoint was the time to pain relief. Secondary endpoints were quality of life (QoL), fatigue, pain, overall survival, bone survival, local control, pathological fracture, pain-free internal and neurological deficit. The baseline examination shall be carried out on the first day of radiotherapy prior to the start of therapy and is scheduled to comprise the comprehensive recording of the sociodemographic data, the recording of the current pain situation, the quality of life, and the current degree of fatigue. The follow-up examinations shall take place at each follow up visit , measuring those parameters recorded at the baseline examination. The further follow-up examinations shall correspond to those carried out as standard after-care investigations.
The secondary endpoints such as fatigue and quality of life shall be recorded using validated questionnaires (EORTC QLQ FA13 and EORTC QLQ BM22. All patients will also be asked to record their pain history using a pain diary (documentation of medication daily during treatment, once weekly after the end of treatment, VAS pain scale). Furthermore, the local control was assessed by means of CT images taken prior to, three and six months after RT. The pain response was documented on the VAS (range 0-10). Complete response (CR) was defined as VAS = 0 after three and six months, partial response (PR) as an improvement by at least two score points after three and six months. Overall survival (OS) was defined as time from initial diagnosis until death, bone survival as time from initial diagnosis of spinal bone metastasis until death.
In each case, the treatment plan was designed based on tumor geometry, proximity to the spinal cord, and location. The planning tumor volume (PTV) was defined as equal to gross tumor volume (GTV). The spinal cord, cauda equina, nerve roots, and bowel were contoured as organs at risk (OARs) and critical structures. An inverse treatment planning method along with a linear optimization algorithm were employed. The target volume was designated to include either the GTV and the entire vertebral body (WB group) or only the GTV (PB group) at each spinal level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| partial body group | Experimental | Radiation: 10x(3-5) Gy IMRT10x(3-5) Gy IMRT on partial vertebral body |
| whole body group | Active comparator | Radiation: 10x3 Gy IMRT10x3 Gy IMRT on whole vertebral body |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with a histologically confirmed tumor diagnosis, with secondary -diagnosed solitary/multiple spinal bone metastases
- Indication for RT of the spinal bone metastases
- Maximal two irradiated vertebral-bodies per region
- Maximal two different vertebral regions
- Age: between 18 and 80 years
Key exclusion criteria (7 listed)
- Multiple myeloma or lymphoma
- Significant neurological or psychiatric disorders, including dementia and epileptic seizures
- Earlier RT at the current irradiated site
- Other severe disorders that in the judgement of the study director may prevent the patient's participation in the study
- Lacking or diminished legal capacity
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 |
|---|---|---|
| 10x(3-5) Gy IMRT10x(3-5) Gy IMRT on partial vertebral body for spinal metastases | Radiation | partial body group |
| 10x3 Gy IMRT10x3 Gy IMRT on whole vertebral body for spinal metastases | Radiation | whole body group |
Primary outcome
the time to pain relief
Time frame: 3 months after treatment
3 secondary outcomes
quality of life measured on an EORTC BM22 questionnaire
Time frame: 3 and 6 months after therapy completed
Overall survival
Time frame: 1 year
local control
Time frame: 3 months after therapy completed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 10x(3-5) Gy IMRT and 10x3 Gy IMRT in people with Pain, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
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 7 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 23 Nov 2016. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the time to pain relief (time frame: 3 months after treatment). 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 23 Nov 2016.