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

NCT ID: NCT04947280

Last Updated: 2021-07-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2026-12-31

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.

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.

Conditions

Bone Metastases; Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fractionated Stereotatic Radiation Therapy

Group Type: EXPERIMENTAL

Fractionated Stereotatic Radiation Therapy

Intervention Type: RADIATION

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

Interventions

Fractionated Stereotatic Radiation Therapy

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

Intervention Type: RADIATION

Other Intervention Names

Stereotatic Fractionated Radiation

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhaozhi Yang, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhaozhi Yang, MD, Ph.D

Role: CONTACT

yzzhi2006@yahoo.com.cn

8618017317126

Wei Shi, MD, Ph.D

Role: CONTACT

wei.shi118@foxmail.com

8618121299680

Other Identifiers

FDRT-BC012

Identifier Type: -

Identifier Source: org_study_id