Metastatic Cancer Clinical Trial
Official title:
A Pilot Study to Assess the Safety and Efficacy of Preoperative Stereotactic Body Radiotherapy for the Treatment of Metastatic Disease in Bone Requiring Surgical Stabilization
| NCT number | NCT05038124 |
| Other study ID # | 21-216 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | July 30, 2021 |
| Est. completion date | July 2025 |
The purpose of this study is to test the safety of stereotactic body radiation therapy (SBRT) followed by surgical stabilization within 1 week. All participants will have metastatic cancer in the bone (bone metastases), and they will be at risk of pathologic fracture (broken bone caused by a disease). Another purpose of this study is to see if the treatment approach of SBRT followed by surgical stabilization within 1 week prevents cancer from returning to the bone.
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | July 2025 |
| Est. primary completion date | July 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Diagnosis of metastatic cancer with radiologic evidence of skeletal metastases - Treatment target involving humerus, radius, pelvis, sacrum, femur, or tibial diaphysis - Age at enrollment =18 years - Life expectancy >3 months - Ability to tolerate radiation simulation and treatment with immobilization of involved anatomic site - Surgical candidate, as determined by the treatment team - Ability to obtain informed consent from patient or legally authorized representative in the setting of patient with impaired decision-making capacity. - Must agree to practice an effective contraceptive method (for those with reproductive potential) Exclusion Criteria: - Prior radiotherapy to the treatment site - Prior surgery involving the treatment site - Tumor volume or distribution precluding effective SBRT - Expected skin dose at the operative site =9 Gy - Imminently impending fracture requiring immediate stabilization surgery - Involvement of proximal tibia - Autoimmune connective tissue disorder - Administration of radiosensitizing medication 3 days before, during, and 3 days after RT - Active infection - Absolute neutrophil count <1.0 - Pregnancy |
| Country | Name | City | State |
|---|---|---|---|
| United States | Memorial Sloan Kettering Basking Ridge | Basking Ridge | New Jersey |
| United States | Memorial Sloan Kettering Cancer Commack | Commack | New York |
| United States | Memorial Sloan Kettering Westchester | Harrison | New York |
| United States | Memorial Sloan Kettering Monmouth | Middletown | New Jersey |
| United States | Memorial Sloan Kettering Bergen | Montvale | New Jersey |
| United States | Memorial Sloan Kettering Cancer Center (All protocol activities) | New York | New York |
| United States | Memorial Sloan Kettering Nassau | Uniondale | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Memorial Sloan Kettering Cancer Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | risk of major wound complications | Major wound complications are defined as reoperation for wound revision, clinically diagnosed surgical site infection, readmission for wound care, or prolonged (>3 weeks postoperatively) active wound care. | 6 weeks after preoperative SBRT | |
| Secondary | rate of local control | Failure of local control is defined as a new lesion within the radiation or surgical field, significant progression of an existing lesion, or reoperation or reirradiation due to tumor progression. | 1 year |
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