Radiation Therapy Clinical Trial
Official title:
A Clinical Trial of Stereotactic Radiotherapy on Spinal Metastasis
A single-center observational clinical trial will be performed for metastatic spinal tumors by stereotactic radiotherapy using TomoTherapy. In this study, we will explore the local control rate (LCR), disease-free progression time (PFS), overall survival time (OS), and pain relief in patients with spinal metastasis, so as to provide a basis for developing relevant guidelines or consensus.
In this observational single-arm study, a total of 45 patients with metastatic spinal tumors will be enrolled. The patients were aged between 18 and 75 years old. And all the subjects should meet the inclusion criteria and sign the informed consent. Meanwhile, the patients' medical history characteristics, including gender, age, imaging data (X-ray, CT, MRI, or PET-CT, etc.), primary tumor type, pathological type, previous treatment, previous disease history, tumor markers and bone metabolism indexes were collected and recorded on the CRF. The metastatic spinal tumors by stereotactic radiotherapy(SBRT) using TomoTherapy. The adiotherapy dose is 6Gy×5Fx, 5Gy×5Fx or 4Gy×5Fx according to the irradiation site. Treatment should be interrupted if there is severe bone marrow suppression, vertebral compression fracture, or radiation myelitis. The adjacentnormal tissue constrains refer to the UK SABR Consortium Guidelines (2022 version). Follow-up was performed 1 month after radiotherapy, thereafter every 3 months for 1-4 years. The parameters includ blood routine, liver and kidney function, bleeding and coagulation function, bone metabolism index, tumor markers, bone metastasis imaging examination. Tumor response will refer to the Cancer Response Criteria and Bone Metastases: RECIST 1.1, MDA and PERCIST. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04324645 -
Active Symptom Monitoring in Patients Undergoing Radiation Therapy for Thoracic Malignancies
|
||
| Completed |
NCT04776083 -
Radiotherapy to the Primary in Metastatic Non-small Cell Lung Cancer Patients
|
Phase 3 | |
| Completed |
NCT01635270 -
Phase 2 Study Evaluating Mid-position Strategy in Radiotherapy Treatment for Patients With a Locally Advanced Non-small Cell Lung Carcinoma
|
Phase 2 | |
| Terminated |
NCT03724422 -
HO Prophylaxis Therapy for Distal Humerus Fractures
|
N/A | |
| Recruiting |
NCT03731130 -
Prospective Observational Trial to Evaluate Quality of Life After Neoadjuvant Radiation or Chemoradiation Followed by Surgery in Patients With Rectal Cancer
|
||
| Recruiting |
NCT04983095 -
Metastasis Directed Stereotactic Body Radiotherapy for Oligo Metastatic Hormone Sensitive Prostate Cancer
|
Phase 3 | |
| Recruiting |
NCT05721053 -
Improving Outcomes for Older Adults Undergoing Radiation Therapy
|
||
| Active, not recruiting |
NCT04764227 -
Phase II Study of Postoperative Concurrent Chemoradiotherapy for Esophageal Squamous Cell Carcinoma (ESO- Shanghai 17)
|
Phase 2 | |
| Not yet recruiting |
NCT05821452 -
Immunotherapy Plus Chemotherapy vs. Chemoradiotherapy for Thoracic Squamous Esophageal Carcinoma
|
Phase 2 | |
| Recruiting |
NCT05335148 -
Study to Evaluate the Safety of Colchicine
|
Phase 1 | |
| Recruiting |
NCT04362306 -
Radiation Oncology Patient Medical Physics Intervention Study
|
N/A | |
| Completed |
NCT01917890 -
Radiosensitizing and Radioprotectve Effects of Curcumin in Prostate Cancer
|
N/A | |
| Not yet recruiting |
NCT05648253 -
Hyivy Device in Post-radiation Patients
|
N/A | |
| Completed |
NCT03235427 -
The CAROLE (CArdiac Related Oncologic Late Effects) Study
|
||
| Recruiting |
NCT03142425 -
Blood Test to Predict Radiation Response and Toxicity in Patients Undergoing Radiation Therapy
|
||
| Recruiting |
NCT05406063 -
Stereotactic Multiple Fraction Radiotherapy for Non-spine Bone Metastases
|
N/A | |
| Recruiting |
NCT03213925 -
Neoadjuvant Chemotherapy Followed by Radiotherapy Alone in Patients With Breast Cancer
|
Phase 2 | |
| Recruiting |
NCT03071289 -
A Trial Comparing Observation With Radiation on Pelvic Lymphocysts After Radical Hysterectomy of Cervical Cancer
|
Phase 3 | |
| Recruiting |
NCT06128863 -
Pembrolizumab in Combination With Eftilagimod Alpha and Radiotherapy in Neoadjuvant Treatment of Patients With Soft Tissue Sarcoma - EFTISARC-NEO Trial
|
Phase 2 | |
| Recruiting |
NCT05351294 -
Assessment of Early Radiation Oncology Involvement Alongside Standard Oncologic Care in the Managemet
|
Phase 3 |