Bone MetastasesNCT05665790
Primary Lesion Treatment for Bone Metastases
A study testing radiotherapy and palliative surgery in people with Bone Metastases, run by Shanghai 6th People's Hospital.
Trial summary
This study will carry out a prospective cohort study to study the effect of different primary leison treatment modes on disease control, quality of life, economic cost and survival period of patients with bone metastases from breast cancer and lung cancer by giving radiotherapy or palliative surgery or not giving… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Metastases
- What is being tested?
- radiotherapy and palliative surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Mar 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HR positive breast cancer patients with bone metastasis or Non-small-cell lung cancer patients with bone metastasis；
- Aged over 18;
- ECOG：0-1；
- Patients who benefit clinically(CR+PR) after 6 months of treatment.
Who cannot join
- The expected life span is less than 3 months;
- Have serious cardiovascular and cerebrovascular diseases, blood coagulation dysfunction, and cannot tolerate surgery;
- Allergies to narcotic drugs;
- The patient refused the treatment decision of the integrated team.
About this study
Official title: Study on Primary Lesion Treatment for Patients With Bone Metastases
This study will carry out a prospective cohort study to study the effect of different primary leison treatment modes on disease control, quality of life, economic cost and survival period of patients with bone metastases from breast cancer and lung cancer by giving radiotherapy or palliative surgery or not giving local treatment for the primary lesion in patients with bone metastases from breast cancer or lung cancer
- Conditions
- Bone Metastases
- Being tested
- radiotherapy, palliative surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiotherapyRadiation
radiotherapy
palliative surgeryProcedure or surgery
palliative surgery
| Study group | Role | What they receive |
|---|---|---|
| radiotherapy | Experimental | Not described Receives: Radiation: radiotherapy |
| palliative surgery | Experimental | Not described Receives: Procedure: palliative surgery |
| no primary leison treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control rate at 1 year
Disease control rate
Measured: 1 year
Secondary outcomes (2)
Progression-Free Survival
Measured: 1 year
Overall Survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study startMar 2023 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone MetastasesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Hui, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665790
- Sponsor's protocol ID
- 20221202
- Status last verified
- Feb 2023
- First submitted
- 18 Dec 2022
- Last updated
- 2 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Primary Lesion Treatment for Patients With Bone Metastases
- ClinicalTrials.gov ID
- NCT05665790
- Acronym / sponsor ID
- 20221202
- Conditions
- Bone Metastases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 27 Dec 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.
This study will carry out a prospective cohort study to study the effect of different primary leison treatment modes on disease control, quality of life, economic cost and survival period of patients with bone metastases from breast cancer and lung cancer by giving radiotherapy or palliative surgery or not giving local treatment for the primary lesion in patients with bone metastases from breast cancer or lung cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| radiotherapy | Experimental | Radiation: radiotherapy |
| palliative surgery | Experimental | Procedure: palliative surgery |
| no primary leison treatment | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HR positive breast cancer patients with bone metastasis or Non-small-cell lung cancer patients with bone metastasis；
- Aged over 18;
- ECOG：0-1；
- Patients who benefit clinically(CR+PR) after 6 months of treatment.
Key exclusion criteria (4 listed)
- The expected life span is less than 3 months;
- Have serious cardiovascular and cerebrovascular diseases, blood coagulation dysfunction, and cannot tolerate surgery;
- Allergies to narcotic drugs;
- The patient refused the treatment decision of the integrated team.
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 |
|---|---|---|
| radiotherapyradiotherapy | Radiation | radiotherapy |
| palliative surgerypalliative surgery | Procedure or surgery | palliative surgery |
Primary outcome
Disease control rate at 1 year
Time frame: 1 year
Disease control rate
2 secondary outcomes
Progression-Free Survival
Time frame: 1 year
Overall Survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
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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 radiotherapy and palliative surgery in people with Bone Metastases, run by Shanghai 6th People's Hospital.
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 4 inclusion and 4 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 2 Mar 2023. 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?
Disease control rate at 1 year (time frame: 1 year). 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 2 Mar 2023.