Single Arm Phase II Study of Fractionated Stereotatic Radiation Therapy (FSRT) for Bone Metastases in Breast Cancer

Breast Cancer Clinical Trial

Official title:

Single Arm Phase II Study of Fractionated Stereotatic Radiation Therapy (FSRT) for Bone Metastases in Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04947280
• Other study ID #: FDRT-BC012
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 1, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2021
• Source: Fudan University
• Contact: Zhaozhi Yang, MD, Ph.D
• Phone: 8618017317126
• Email: yzzhi2006[@]yahoo.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Fractionated stereotatic radiation therapy (FSRT) that very precisely delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. The purpose of this study is to find out if FSRT is safe and effective in the treatment of metastatic spinal tumors of breast cancer.

Description:

Eligible breast cancer patients with bone metastases will be treated with FSRT. 9-10 Gy x 3Fx or 6-7 Gy x 5Fx image-guided fractionated stereotatic radiation therapy will be used.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Diagnosis of invasive breast cancer

2. Signed informed consent

3. Bone metastases (confirmed by MRI within 4 weeks of enrollment).

4. Paraosseous soft tissue = 5cm. The tumour could involve the vertebral column, but did not have to, nor did it need to enter the spinal canal.

5. KPS = 40 or ECOG 0-2.

6. The tumor is at least 2 mm away from the spinal cord. If the tumor is closer than 2 mm, surgical resection is required prior to FSRT or the total prescription dose of spinal cord is strictly limited.

7. Failure of previous conventional external beam radiotherapy or surgery, residual tumor after surgery, medical inoperability, and refusal to undergo surgery.

8. A maximum of three distinct noncontiguous spinal metastases per patient was allowed, and each of the separate sites may have involvement of 2 contiguous vertebral bodies.

9. Patients have sufficient bone marrow reserve and liver and kidney function: neutrophil count = 1500 cells / mm3; platelet count = 70000 / mm3; hemoglobin (Hgb) = 8.0 g / dl; if there is liver metastasis, AST and ALT < 3x ULN

10. The interval between systemic chemotherapy is more than 2 weeks, and the side effects recovery from previous treatment = grade 1

11. Patients receiving bisphosphonates, endocrine or targeted therapy at the same time were not included

Exclusion Criteria:

1. Patients with mechanically unstable spine or epidural spinal cord compression were excluded; however, patients with previously documented spinal cord compression that had been decompressed and stabilized were eligible. Patients with > 50% loss of vertebral body height were excluded.

2. Patients in whom a delay in initiating treatment might have adversely affected neurological outcome.

3. Patients with a pacemaker, unable to undergo MR imaging and unable to lie flat for at least 30 minutes.

4. Patients who had a history of previous radiotherapy to the spine at the current level of interest.

5. Patients who had received prior external-beam irradiation to the spine within 3 months of registration.

6. Patients who had received systemic radiotherapy (Strontium-89) within 30 days of starting protocol treatment.

7. Patients who had received chemotherapy within 2 weeks of starting protocol treatment.

8. Patients who are unwilling or unable to receive regular follow-up.

9. The patients judged by the researchers who could not be included in some special cases.

10. Serious complications: cardiovascular disease, end-stage renal disease, serious liver disease, infection, et al.

11. Pregnant women.

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Bone Metastases
• Bone Neoplasms
• Breast Cancer
• Breast Neoplasms
• Neoplasm Metastasis

Intervention

Radiation:
• Fractionated Stereotatic Radiation Therapy
Participants prescribed to receive 9 Gy x 3 or 10 Gy x3 image-guided fractionated stereotatic radiation therapy.

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Control Rate	Determine the local control rate of FSRT in patients with bone metastasis of breast cancer	3 years
Secondary	Pain Control	Evaluate whether FSRT improves pain control as measured by Brief Pain Inventory (BPI) after FSRT in patients with spinal metastasis of breast cancer	3 years
Secondary	Overall Survival	Time from the date of informed consent until to the date of death, regardless of the cause of death	3 years
Secondary	Progression Free Survival	Time from the date of radiotherapy to the investigator-determined date of progression or death due to any cause, whichever occurs first	3 years
Secondary	Quality of Life	Evaluate the quality of life according to EORTC QLQ-BM22	3 years
Secondary	Vertebral Fracture and Radiation Myelitis	Determine the incidence of bone fracture and radiation myelitis	3 years