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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Bone Metastases
• Intervention / Treatment: Radiation: Fractionated Stereotatic Radiation Therapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Zhaozhi Yang, MD, Ph.D; Phone Number: 8618017317126; Email: yzzhi2006@yahoo.com.cn
• Study Contact Backup: Name: Wei Shi, MD, Ph.D; Phone Number: 8618121299680; Email: wei.shi118@foxmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Fudan University Shanghai Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fractionated Stereotatic Radiation Therapy	Radiation: Fractionated Stereotatic Radiation Therapy; Participants prescribed to receive 9 Gy x 3 or 10 Gy x3 image-guided fractionated stereotatic radiation therapy.; Other Names: Stereotatic Fractionated Radiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local Control Rate	Determine the local control rate of FSRT in patients with bone metastasis of breast cancer	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Overall Survival	Time from the date of informed consent until to the date of death, regardless of the cause of death	3 years
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
Quality of Life	Evaluate the quality of life according to EORTC QLQ-BM22	3 years
Vertebral Fracture and Radiation Myelitis	Determine the incidence of bone fracture and radiation myelitis	3 years

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Zhaozhi Yang, MD, Ph.D, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: June 23, 2021
• First Posted (Actual): July 1, 2021

Study Record Updates

• Last Update Posted (Actual): July 1, 2021
• Last Update Submitted That Met QC Criteria: June 23, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Hematologic Diseases; Breast Diseases; Musculoskeletal Diseases; Neoplastic Processes; Bone Diseases; Breast Neoplasms; Neoplasm Metastasis; Bone Neoplasms; Bone Marrow Diseases
• Other Study ID Numbers: FDRT-BC012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No