Not yet recruitingNCT05665790Updated Mar 2, 2023

Primary Lesion Treatment for Bone Metastases

An interventional study of radiotherapy and palliative surgery in Bone Metastases, sponsored by Shanghai 6th People's Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-02.

Sponsored by Shanghai 6th People's Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

Primary completion was expected by Mar 2025, 1 year 7 months ago, but the record still lists the study as not yet recruiting.

Phase: Not applicable
Study type: Interventional
Enrollment: 400
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study 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 local treatment for the primary lesion in patients with bone metastases from breast cancer or lung cancer

Conditions studied

Bone Metastases

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In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's planned enrollment of 400 is above the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Shanghai 6th People's Hospital is the lead sponsor of 69 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 400 participants (estimated)

Study arms

Experimental
radiotherapy
Radiation: radiotherapy
Experimental
palliative surgery
Procedure: palliative surgery
No intervention
no primary leison treatment

Interventions

Radiationradiotherapy
radiotherapy
Procedurepalliative surgery
palliative surgery

What researchers measure

Primary outcomes

Disease control rate at 1 year
Disease control rate
Time frame: 1 year

Secondary outcomes

Progression-Free Survival
Time frame: 1 year
Overall Survival
Time frame: 1 year

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05665790
Lead sponsor: Shanghai 6th People's Hospital
Responsible party: Zhao Hui (Principal Investigator, Shanghai 6th People's Hospital) — Principal investigator
First posted: Dec 27, 2022
Start date: Mar 2023 (estimated)
Primary completion: Mar 2025 (estimated)
Completion: Mar 2026 (estimated)
Last update: Mar 2, 2023

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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