Spinal Metastases Clinical Trial
Official title:
An Observational Study of Novel Survival Prediction Algorithm as Clinical Decision Support for Patients With Non-Small-Cell Lung Cancer (NSCLC) Spinal Metastasis
Verified date | October 2020 |
Source | Ruijin Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to learn whether our own made predictive algorithm can be used as a clinical practical decision support for patients with NSCLC spinal metastasis. The scoring system consists of the use of EGFR-TKI, KPS, Age, SCC, CA125 and smoking history. By predicting survival doctors could determine which patients are suitable for palliative therapy.
Status | Recruiting |
Enrollment | 140 |
Est. completion date | November 1, 2022 |
Est. primary completion date | November 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Diagnosis by biopsy: Non-small-cell lung cancer, including non-squamous carcinoma and squamous cell carcinoma. - Diagnosis through both nucleotide bone scan and MRI or PET-CT: spinal metastasis. - Age 18-75 years. - Have been or is about to be treated according to NCCN panel recommendation. Exclusion Criteria: - Diagnosis by biopsy: other tumors. - Irregular follow-up and lost follow-up - Withdraw from the study for any reason |
Country | Name | City | State |
---|---|---|---|
China | Ruijin Hospital Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Ruijin Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Survival | Accuracy and sensitivity of novel survival prediction algorithm derived from differences between the predicted and actual survival of NSCLC spinal metastasis patients from 3 different risk groups. | Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years | |
Secondary | Primary and Metastatic Lesions | Differences in the primary and metastatic lesions after therapy according to NCCN suggestion of NSCLC spinal metastasis patients from 3 different risk groups. | Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years | |
Secondary | Serum Markers | Differences in the serum markers after therapy according to NCCN suggestion of NSCLC spinal metastasis patients from 3 different risk groups. | Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years | |
Secondary | Visceral Metastasis | The correlation between visceral metastasis and overall survival (OS) of NSCLC spinal metastasis patients | Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years | |
Secondary | Visual Analogue Scale (VAS) | Assessment of pain level (1-10, higher value represents more pain) | Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years | |
Secondary | Ambulatory Status | Assessment of walking ability | Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years | |
Secondary | EORTC Quality of Life Questionnaire (QLQ) Bone metastasis (BM) 22, | Assessment of quality of life (22-88, higher value represents worse quality of life) | Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years | |
Secondary | Modified Frankel grade | Assessment of neurological function (A-E, higher value represents better function) | Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years | |
Secondary | The Spinal Instability Neoplastic Score (SINS) | Assessment of spinal instability (0-18, higher value represents worse instability) | Every 6 months from date of diagnosis of NSCLC spinal metastasis until the date of death from any cause, assessed up to 3 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01347307 -
Stereotactic Body Radiotherapy for Spine Tumors
|
N/A | |
Terminated |
NCT00593320 -
Stereotactic Radiosurgery (SRS) for Spine Metastases
|
N/A | |
Recruiting |
NCT05575323 -
Randomized Trial on Same-day SBRT and Surgical Stabilization for Symptomatic Spinal Metastases
|
N/A | |
Completed |
NCT02987153 -
Kypho-Intra Operative Radiation Therapy (IORT) for Localized Spine Metastasis, Phase I/II Study
|
N/A | |
Terminated |
NCT02407795 -
Conventional With Stereotactic Radiotherapy for Pain Reduction and Quality of Life in Spinal Metastases
|
N/A | |
Completed |
NCT01365715 -
Preoperative Embolization in Surgical Treatment of Spinal Metastases.
|
N/A | |
Recruiting |
NCT04863612 -
SBRT in the Management of Solid Spinal Metastases
|
||
Recruiting |
NCT04242589 -
Trial of Combined Radiotherapy and Vertebroplasty for Patients With Painful Metastatic Spinal Lesions
|
Phase 2 | |
Recruiting |
NCT01849510 -
Efficacy of Dose Intensified Radiotherapy of Spinal Metastases by Hypofractionated Radiation and IGRT hfSRT Mediated Boost
|
Phase 2 | |
Not yet recruiting |
NCT06244264 -
The Safety and Efficacy of Autologous Transfusion in Spinal Surgery for Lung Cancer With Spinal Metastasis
|
N/A | |
Not yet recruiting |
NCT06220071 -
Multicentric European Study In Patients With Vertebral Metastases
|
||
Completed |
NCT01290562 -
Stereotactic Body Radiotherapy (SBRT) for Spinal/Para-Spinal Metastases (Spine SBRT)
|
Phase 2 | |
Recruiting |
NCT06120426 -
En Bloc Resection Versus Separation Surgery Combined With Radiotherapy for the Treatment of Spinal Oligometastatic Tumor.
|
||
Completed |
NCT03224650 -
Validation of Novel Predictive Score for Patients With Spinal Metastases
|
||
Completed |
NCT02512965 -
Study Comparing Stereotactic Body Radiotherapy vs Conventional Palliative Radiotherapy (CRT) for Spinal Metastases
|
N/A | |
Not yet recruiting |
NCT06093854 -
Intraoperative Radiotherapy in Treating Spinal Metastases
|
N/A | |
Completed |
NCT02364115 -
Randomized Trial Comparing Conventional Radiotherapy With Stereotactic Radiotherapy in Patients With Bone Metastases - VERTICAL Study
|
N/A | |
Recruiting |
NCT03398915 -
The European Robotic Spinal Instrumentation (EUROSPIN) Study
|
||
Not yet recruiting |
NCT05173467 -
Robot-assisted Invasion-controlled Surgery Versus Traditional-open Surgery Against Metastatic Spinal Tumor
|
N/A | |
Recruiting |
NCT04248543 -
Quantitative MRI for Functional Assessment Following SBRT for Spinal Metastases
|
N/A |