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

NCT04947280 | Recruiting Phase 1

• 1 other identifier: FDRT-BC012
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bone Metastases; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Local Control Rate

  Determine the local control rate of FSRT in patients with bone metastasis of breast cancer

  3 years

Secondary Outcomes (5)

• Pain Control

  3 years

• Overall Survival

  3 years

• Progression Free Survival

  3 years

• Quality of Life

  3 years

• Vertebral Fracture and Radiation Myelitis

  3 years

Study Arms (1)

Fractionated Stereotatic Radiation Therapy

EXPERIMENTAL

Radiation: Fractionated Stereotatic Radiation Therapy

Interventions

Fractionated Stereotatic Radiation Therapy RADIATION

Participants prescribed to receive 9 Gy x 3 or 10 Gy x3 image-guided fractionated stereotatic radiation therapy.

Also known as: Stereotatic Fractionated Radiation

Fractionated Stereotatic Radiation Therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of invasive breast cancer
• Signed informed consent
• Bone metastases (confirmed by MRI within 4 weeks of enrollment).
• 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.
• KPS ≥ 40 or ECOG 0-2.
• 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.
• Failure of previous conventional external beam radiotherapy or surgery, residual tumor after surgery, medical inoperability, and refusal to undergo surgery.
• 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.
• 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
• The interval between systemic chemotherapy is more than 2 weeks, and the side effects recovery from previous treatment ≤ grade 1
• Patients receiving bisphosphonates, endocrine or targeted therapy at the same time were not included

You may not qualify if:

• 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.
• Patients in whom a delay in initiating treatment might have adversely affected neurological outcome.
• Patients with a pacemaker, unable to undergo MR imaging and unable to lie flat for at least 30 minutes.
• Patients who had a history of previous radiotherapy to the spine at the current level of interest.
• Patients who had received prior external-beam irradiation to the spine within 3 months of registration.
• Patients who had received systemic radiotherapy (Strontium-89) within 30 days of starting protocol treatment.
• Patients who had received chemotherapy within 2 weeks of starting protocol treatment.
• Patients who are unwilling or unable to receive regular follow-up.
• The patients judged by the researchers who could not be included in some special cases.
• Serious complications: cardiovascular disease, end-stage renal disease, serious liver disease, infection, et al.
• Pregnant women.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Zhaozhi Yang, MD, Ph.D

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhaozhi Yang, MD, Ph.D

CONTACT

8618017317126; yzzhi2006@yahoo.com.cn

Wei Shi, MD, Ph.D

CONTACT

8618121299680; wei.shi118@foxmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: July 1, 2021
• Study Start: January 1, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 1, 2021

Record last verified: 2021-04

Locations

CN (1)