Surgery Clinical Trial
Official title:
En Bloc Resection Versus Separation Surgery Combined With Radiotherapy for the Treatment of Spinal Oligometastatic Tumor-A Multi-center, Prospective, Randomized, Controlled Study.
NCT number | NCT06120426 |
Other study ID # | 2023SL050 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2023 |
Est. completion date | July 1, 2027 |
The purpose of this clinical trial is to explore the impact of En bloc surgery and separation surgery combined with radiation therapy on the prognosis and survival of patients with spinal oligometastatic cancer, describe the clinical results, and optimize future treatment goals
Status | Recruiting |
Enrollment | 182 |
Est. completion date | July 1, 2027 |
Est. primary completion date | July 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - 1) Be able to sign written informed consent. - 2) Age range from 18 to 75 years old, regardless of gender. - 3) Within conservative treatment, the patient still has uncontrollable pain, metastatic cancer lesions that still progress, spinal instability/potential instability, or symptoms of spinal cord/nerve compression. - 4) After the patient underwent Positron Emission Tomography-Computed Tomography (PET-CT) examination, it was indicated that there were no more than 3 metastatic organs and no more than 5 metastatic lesions in the whole body of cancer. Among them, there was at least 1 spinal metastasis and at most 5 spinal metastases. - 5) Imaging examinations (enhanced MRI, enhanced CT, X-ray) indicate the presence of spinal metastasis. - 6) The expected survival period is = 6 months. - 7)No other surgical contraindications Exclusion Criteria: - 1) Primary tumors of the spine or multiple tumors of the body, with>3 metastatic organs and>5 metastatic sites. - 2) Previously underwent spinal surgery, or received radiotherapy for the responsible segment of this treatment. - 3) Severe heart, lung, liver, kidney or other diseases affecting the surgery. - 4) Having cognitive impairment, sensory aphasia, and inability to understand basic instructions. - 5) Participated in clinical trials of other drugs or medical devices within 3 months prior to enrollment. - 6) Infectious diseases. - 7) Refuse to follow up or participate. - 8) The researchers determine that the patients are not suitable for enrollment this clinical trail. |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Changzheng hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Changzheng Hospital | First Affiliated Hospital, Sun Yat-Sen University, Henan Cancer Hospital, Peking University People's Hospital, Peking University Third Hospital, Sun Yat-sen University, The First Affiliated Hospital of Nanchang University, The Third Affiliated Hospital of Southern Medical University, Tianjin Hospital, Zhejiang University |
China,
Barzilai O, Laufer I, Yamada Y, Higginson DS, Schmitt AM, Lis E, Bilsky MH. Integrating Evidence-Based Medicine for Treatment of Spinal Metastases Into a Decision Framework: Neurologic, Oncologic, Mechanicals Stability, and Systemic Disease. J Clin Oncol. — View Citation
Barzilai O, McLaughlin L, Amato MK, Reiner AS, Ogilvie SQ, Lis E, Yamada Y, Bilsky MH, Laufer I. Predictors of quality of life improvement after surgery for metastatic tumors of the spine: prospective cohort study. Spine J. 2018 Jul;18(7):1109-1115. doi: — View Citation
Chang JH, Shin JH, Yamada YJ, Mesfin A, Fehlings MG, Rhines LD, Sahgal A. Stereotactic Body Radiotherapy for Spinal Metastases: What are the Risks and How Do We Minimize Them? Spine (Phila Pa 1976). 2016 Oct 15;41 Suppl 20(Suppl 20):S238-S245. doi: 10.109 — View Citation
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Dupuy DE, Liu D, Hartfeil D, Hanna L, Blume JD, Ahrar K, Lopez R, Safran H, DiPetrillo T. Percutaneous radiofrequency ablation of painful osseous metastases: a multicenter American College of Radiology Imaging Network trial. Cancer. 2010 Feb 15;116(4):989 — View Citation
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Kumar N, Madhu S, Bohra H, Pandita N, Wang SSY, Lopez KG, Tan JH, Vellayappan BA. Is there an optimal timing between radiotherapy and surgery to reduce wound complications in metastatic spine disease? A systematic review. Eur Spine J. 2020 Dec;29(12):3080 — View Citation
Murali N, Turmezei T, Bhatti S, Patel P, Marshall T, Smith T. What is the effectiveness of radiofrequency ablation in the management of patients with spinal metastases? A systematic review and meta-analysis. J Orthop Surg Res. 2021 Nov 6;16(1):659. doi: 1 — View Citation
Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caa — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival(OS) | On the basis of maintaining systemic treatment, compare the overall survival period of En bloc surgery and separation surgery combined with radiation therapy for patients with spinal oligometastatic cancer, after surgery until death due to primary disease or responsible segment. | after surgery until death due to primary disease or responsible segment | |
Secondary | Local Control Rate(LRC) | Based on the Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1), it is defined as a 20% increase in the total diameter of the target lesion observed on imaging from the beginning of the patient's current treatment to baseline. | a 20% increase in the total diameter of the target lesion observed on imaging from the beginning of the patient's current treatment to baseline. | |
Secondary | Progression-Free Survival(PFS) | The period between the patient receiving this treatment and observing local progression or death from any cause. Based on the changes in patient imaging and neurological function, comprehensively evaluate whether the local lesion of the spine is progressing. | The period between the patient receiving this treatment and observing local progression or death from any cause. | |
Secondary | Brief Pain inventory | Use the Brief Pain Inventory (BPI) to score the pain levels 1 day before surgery, 2 weeks after surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery, and 12 months after surgery. | 1 day before surgery, 2 weeks after surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery, and 12 months after surgery. | |
Secondary | EORTC Quality of Life Questionnaire - Core 30 | Evaluate the quality of life of patients 1 day before surgery, 2 weeks after surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery, and 12 months after surgery using EORTC Quality of Life Questionnaire - Core 30 | 1 day before surgery, 2 weeks after surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery, and 12 months after surgery | |
Secondary | Complication | The incidence of vertebral compression fractures: X-ray examination of the surgical area was performed on the first day, within 3 months, within 6 months, and within 12 months respectively.
Wound complications: Erythrocyte Sedimentation Rate (ESR) and C-reactive protein tests were performed on the first day after surgery. Observe and record the incidence of incision infection, incision non healing, and the need for debridement within 1 month after surgery. Other complications: Observe whether the patient experiences bleeding, pulmonary infection, or pulmonary embolism within one month after treatment. |
1 month, 3 months, 6 months, and 12 months after surgery. |
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