Neoplasms

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Neoplasm Metastasis

Neoplastic Processes

Radio-Frequency device designed for palliative treatments of patient with painful metastatic bone tumors involving vertebral bodies, sacrum, iliac crest and peri-acetabulum

SPINERY

Stefano Marini, Dr.

Luigi Manfré, Prof.

Francesca Amato, Dr.

Francesco Amato, Dr.

Mario Muto, Prof

Matteo Bellini, Dr

Matteo Bellini, Dr.

SPINERY is a Radiofrequency (RF) device designed for palliative treatment of patients with painful metastatic bone tumors involving vertebral bodies, sacrum, iliac crest and peri-acetabulum.

In particular, SPINERY is conceived for pain reduction in patients affected by metastatic bone tumors involving the vertebral bodies, sacrum, iliac crest and periacetabulum, in patients with indication for Standard Therapy and in patients who have failed, not candidates or refuse Standard Therapy.

Primary objective of the SPARTA Study is to demonstrate that SPINERY RF device is effective in short-term (3 months) pain reduction in patients affected by metastatic bone tumors and to demonstrate that SPINERY RF device is safe in the RF ablation treatment of metastatic bone tumors, without causing device-related adverse events including, in particular, nerve injury.

Primary objective hypothesis will be obtained with Brief Pain Inventory (BPI) scale performance questionnaire in terms of palliative treatment.

Change of Worst Pain Score expressed as average reduction of 2 BPI (Brief Pain Inventory) scores will be calculated as:

μc = worst-pain 3-month - worst-pain baseline

A negative average value for change in pain represents a lowering of the subject's pain score (an improvement, or reduction in pain) and a positive value represents an increase in the subject's pain score (a worsening or increase in pain). Worst pain score at the target treatment site will be collected from the BPI in the past 24 hours.

Prospective, Multicenter, no control group

SPINERY™ A Novel Radio-Frequency Tumor Ablation Device Study

Clinical Study of SPINERY™ A Novel Radio-Frequency Tumor Ablation Device for Spine Metastatic Tumors

Change of Worst Pain Score expressed as average reduction of 2 BPI scores: Thoracic/Lumbar/ Peri-acetabulum/Iliac Crest/Sacrum RF Ablation

Completion (%) of the ablation procedure without device-related adverse events including in particular nerve injury

Axon srl

Wounds and Injuries

Fractures, Bone

Pharmaceutical Solutions

All Drugs and Chemicals

Bone Density Conservation Agents

Zoledronic Acid

Patients receive RSHF according to : 30 Gy in 5 fractions of 6 Gy spaced 48 hours or 27 Gy in 3 fractions of 9 Gy spaced 48 hours or 20 Gy in 1 fraction. combined with zoledronic acid (4 mg IV slow monthly for 12 months, dose adjusted according to creatinine clearance).

Patients receive only RSHF according to : 30 Gy in 5 fractions of 6 Gy spaced 48 hours or 27 Gy in 3 fractions of 9 Gy spaced 48 hours or 20 Gy in 1 fraction.

All patients receive radiotherapy i.e. treatment on D1, D3 and D5.

Several radiotherapy schemes are possible:

* 20 Gy in 1 fraction;
* 27 Gy in 3 fractions of 9 Gy
* 30 Gy in 5 fractions of 6 Gy. All patients in the experimental arm receive an intravenous injection of at least 15 minutes of 4 mg zoledronic acid every month for 12 months.

The first injection must be made no more than 3 weeks before the first day of radiotherapy. It can be performed up to J1 of radiotherapy.

The injections will be carried out either at the patient's home by the nurses or in the investigator centre.

Zoledronic Acid 4Mg Solution for Injection + Hypo-fractured radiotherapy in stereotactic conditions

All patients receive radiotherapy i.e. treatment on D1, D3 and D5.

Several radiotherapy schemes are possible:

* 20 Gy in 1 fraction;
* 27 Gy in 3 fractions of 9 Gy
* 30 Gy in 5 fractions of 6 Gy.

Hypo-fractured radiotherapy in stereotactic conditions

Stéphane SUPIOT, MD

Stéphanie BATARD, MD

JEAN-CHRISTOPHE FAIVRE, MD

Jean-Christophe FAIVRE, MD

Xavier BUTHAUD, MD

René-Jean BENSADOUN, MD

Ariane LAPIERRE, MD

SEBASTIEN THUREAU, MD

Sébastien THUREAU, MD

Hypo-fractured radiotherapy in stereotactic conditions (RSHF) of bone metastases allows high doses to be delivered to the affected bone segment while sparing adjacent healthy tissues as well as possible. In addition, it not only reduces pain and prevents spinal cord compression, but also improves long-term control of metastatic disease.

Zoledronic acid reduces bone complications. The economic literature shows that stereotactic radiotherapy, like zoledronic acid, are cost-effective strategies in these indications. The objective of this research project is to evaluate the efficiency of adding zoledronic acid to stereotactic radiotherapy in the treatment of vertebral metastases.

Multicentre Medical-economic Study Evaluating the Efficacy of Adding ZOlédronique Acid to STERéotaxique Radiotherapy in the Treatment of Vertebral Metastases

Phase III Randomized, Controlled, Open, Multicentre Medical-economic Study Evaluating the Efficacy of Adding ZOlédronique Acid to STERéotaxique Radiotherapy in the Treatment of Vertebral Metastases

The determination of the DCRR includes Identification of care consumption ; The measurement of costs ; overall survival at 2 years ; Calculation of utilities using the EQ5D-5L questionnaire

Pain control will be assessed using a visual analogue scale (VAS) that measures pain intensity, prevents it, initiates or monitors drug or non-drug treatment, and the Brief Pain inventory, a questionnaire that quickly assesses the severity of pain and its impact on the patient's daily life.

Institut Cancerologie de l'Ouest

Pain

Baseline Assessments and followup assessments are the same for both arms. Control group Intervention: Stereotactic Radiation Therapy only

SRT with Vertebral Augmentation Procedure Baseline Assessments and followup assessments are the same for both arms. Treatment group Intervention: Stereotactic Radiation Therapy with Vertebral Augmentation Procedure

Stereotactic Radiation Therapy

SRT with Vertebral Augmentation Procedure

Shiao Y Woo, MD

The purpose of this study is to determine pain control rate (Percentage of patients in each arm that achieve pain control) at the treated site(s) at 1 month, 2-4 months and 5-6 months post-treatment.

Eligible Vertebral Metastatic Lesion/s-\> randomized-\> SRT versus SRT+ VAP Stereotactic Radiation Therapy(SRT): 16 Gy X 1 Evaluation: prior to treatment; 1 month, 2-4 months, 5-6 months and 1 year post-treatment

Phase II Trial of Stereotactic Radiation Therapy (SRT) Versus SRT Plus Vertebral Augmentation Procedure (VAP) for Vertebral Metastasis

Randomized Phase II Trial of Stereotactic Radiation Therapy (SRT) Versus SRT Plus Vertebral Augmentation Procedure (VAP) for Vertebral Metastasis

To determine pain control rate (Percentage of patients in each arm that achieve pain control) at the treated site(s)at 1 month, 2-4 months and 5-6 months post-treatment and to validate of the movement-related pain score

To estimate the relative quantitative reduction of pain from baseline in patients in each arm.

To estimate the quality of life using the Oswestry Disability Questionnaire

To estimate the feasibility rate of the study procedure (the percentage of patients in overall and each arm that complete the treatment).

To estimate the toxicities of the treatment

To measure the dimensions of the treated vertebra(e) at 1 year

James Graham Brown Cancer Center

University of Louisville

Chair-Radiation Oncology

Baseline Assessments and followup assessments are the same for both arms. Control group Intervention: Stereotactic Radiation Therapy only

Stereotactic Radiation Therapy: SRT only

Control Group

Baseline Assessments and followup assessments are the same for both arms. Treatment group Intervention: Stereotactic Radiation Therapy with Vertebral Augmentation Procedure

SRT with Vertebral Augmentation Procedure: SRT with VAP

Treatment Group

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Trial did not meet enrollment goal. Investigator did not analyze data due to low enrollment and early termination of trial

Dr. Shiao Woo

Data not analyzed due to low enrollment and early termination of study

Numerical Rating Pain Scale (NRPS) Change in Patients

Reduction of Pain Estimate

Quality of Life Estimate

Feasibility Rate Estimation

Toxicity Rate Estimation

Vertebra Measurement

Overall Study

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Breast Neoplasms

Prostatic Neoplasms

Lung Neoplasms

Carcinoma, Renal Cell

Kidney Neoplasms

Renal Cell Carcinoma

Conformal High Dose Intensity Modulated Radiation Therapy to a single asymptomatic local spine metastasis.

Conformal High Dose Intensity Modulated Radiation Therapy 14-16Gy single fraction dosing using 6MV photons

Conformal High Dose Intensity Modulated Radiation Therapy

Ronald McGarry, M.D.

The purpose of this study is to determine if Conformal High Dose Intensity Modulated Radiation Therapy is an appropriate option for treating cancer that has spread to the spinal column. This study involves patients who have been diagnosed with metastatic cancer to the thoracic and lumbar vertebral body levels and currently do not have symptoms caused from the area of concern. The goal is to prove that this is not only a safe form of treatment, but that Conformal High Dose Intensity Modulated Radiation Therapy can reduce the risk of cancer coming back in the area that the investigators treat which may reduce the risk of developing symptoms like pain in the future.

Conformal High Dose Intensity Modulated Radiation Therapy for Disease to Thoracic and Lumbar Spine

Conformal High Dose Intensity Modulated Radiation Therapy for Asymptomatic Metastatic Disease to the Thoracic and Lumbar Spine

Time to any skeletal related event most commonly symptomatic recurrence or progression with pain/neurologic impairment with evidence of radiographic progression (median local progression-free survival).

The number of acute side effects of radiation therapy will be documented (≤ 90 days from start of radiation therapy)

The number of late side effects of radiation therapy will be documented (\> 90 days after the start of radiation therapy)

Ronald McGarry

Professor, Radiation Medicine

Conformal High Dose Intensity Modulated Radiation Therapy

Conformal High Dose Intensity Modulated Radiation Therapy: Conformal High Dose Intensity Modulated Radiation Therapy 14-16Gy single fraction dosing using 6MV photons

Radiation Therapy to Local Spine Metastasis

Never Smoker

Former Smoker

Current Smoker

Smoking Status

Thoracic Spine

Lumbar Spine

Site of Metastasis

Ronal McGarry

Time to Any Skeletal Related Event

Acute Radiation Toxicity

Late Radiation Toxicity

Neoplasms, Second Primary

Breast Diseases

Skin Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Vertebroplasty

Juan F Asenjo, MD

The study aims to evaluate if adding vertebroplasty to radiotherapy, in the treatment of spine metastasis from breast and prostate cancer, is preferable to radiotherapy alone. The investigators hypothesize that, by combining vertebral augmentation with cement and radiotherapy, they could achieve an enhancement in pain relief and level of activities, as well as a decrease in the side effects of multiple medications used for pain control.

Included patients presenting with spinal metastasis secondary to breast or prostate cancer are randomized to two groups, intervention and control. Both groups receive standard radiotherapy, which is currently the gold standard of care for such patients. The intervention group will also receive a vertebroplasty \[single or multiple level(s)\], while the control group will receive a simulated vertebroplasty, where local anesthesia and gentle hand manipulation will be used but the vertebra will not be accessed. The primary outcome is pain relief, though other factors such as quality of life and pain medications will also be evaluated.

There will be an interim analysis after half of the patients have been treated with a follow-up of 3 months. In the analysis, comparisons will be made between the two groups and each patient's individual progress will also be analyzed.

Potential Vertebroplasty Use in the Treatment of Vertebral Metastasis From Breast and Prostate Cancer

Challenging the Paradigm in Pain Relief for Advanced Breast and Prostate Cancer Patients With Vertebral Metastasis: Vertebral Augmentation With Cement Plus Radiotherapy Versus Radiotherapy. A Randomized, Prospective, Double Blind Pilot Study

McGill University Health Centre/Research Institute of the McGill University Health Centre

Blood and Lymph Conditions

Immune System Diseases

Behaviors and Mental Disorders

Lymphoproliferative Disorders

Quality of Life

decompression with or without stabilization; stabilization only; debulking; en bloc resection

Surgical treatment

Silvia Terzi, MD

Perspective observational cohort study in which the data relating to patients affected by one or more vertebral metastases or by vertebral localization of hemolifoproliferative malact and surgical treatment candidates will be collected, which will be recruited at the Complex Structure of Spine Surgery for Oncological and Degenerative Rizzoli Orthopedic Institute starting from the date of approval of the same study.

Patients of both sexes and aged 18 years or older will be included. Patients with primary (benign or malignant) tumors of the vertebrae and patients unable to consent to the study will be excluded from the study.

For each patient, in addition to the demographic data, preoperative information will be collected: type of tumor, involved vertebral levels, presence of pathological fracture, presence of visceral metastases, presence and number of other bone metastases, neurological picture according to Frankel's scale, evaluated pain according to the Visual Analogue Scale (VAS), functional status according to Karnofsky, EuroQoL-5D and SF-36 questionnaires on the quality of life; information related to the intervention itself: access, type of surgical treatment, possible preoperative embolization; intraoperative complications; information at discharge: postoperative complications, pain, neurological picture, functional status; follow-up data: pain, neurological picture, functional status, SF-36 questionnaire, late complications, local recurrence; systemic progression of the disease.

Follow-up checks will be performed at 3 months, 6 months, 12 months, 18 months, 24 and 36 months. The timing of the controls and the examinations requested by the patients will be those of normal clinical practice.

Primary endpoint is the change in quality of life (measured by scores EQ-5D and SF-36) and pain (measured using the VAS score) following surgery compared to pre-operative values.

STUDY DESIGN Analytical Prospective Longitudinal cohort Not checked

RATIONALE OF THE STUDY The improvement of the systemic control of oncological diseases achieved in recent years has led to a considerable increase in patient survival; it was associated with a parallel increase in the onset of symptomatic vertebral metastases.

Such metastases are often associated with pain, mechanical instability of the spine, and even possible neurological deficits, which negatively affect the patient's quality of life and indirectly also on his survival.

The treatment of these metastases is defined by a multidisciplinary approach; surgery is indicated in the presence of mechanical instability, signs of neurological compression, intractable pain, progression of disease during systemic treatment.

The indication and the type of intervention are defined following a reference algorithm (A. Gasbarrini, M. Cappuccio, L. Mirabile, S. Bandiera, S. Terzi, G. Barbanti Bròdano, S. Boriani.) Spinal Metastases: treatment evaluation algorithm Eur Eur Med Pharmacol Sci 2004; 8: 265-274), in collaboration with the team of specialists involved.

Within the multidisciplinary team it is usually the Oncologist who provides an estimate of the prognosis quoad vitam, based on the general status of the patient and the residual therapeutic possibilities.

The goal of surgery is the local control of the disease and the improvement of the patient's quality of life.

Although there are works in the literature that demonstrate the effectiveness of surgical treatment in vertebral metastases, there are few prospective studies in which, in addition to survival, the improvement in the quality of life after the intervention is evaluated, and the improvement over time is maintained.

DESCRIPTION OF THE STUDY The study is monocentric, of a prospective observational type, with a single arm.

The study will collect data relating to patients affected by one or more vertebral metastases or by vertebral localization of hemolymphoproliferative disease candidates for surgical treatment, which will be recruited at the Complex Structure of Spine Surgery for Oncological and Degenerative Address of the Rizzoli Orthopedic Institute starting from date of approval of the study itself.

Patients of both sexes and aged 18 years or older will be included

DATA COLLECTION

For each patient will be collected, in addition to demographic data:

* preoperative information: type of tumor, vertebral levels involved, presence of pathological fracture, presence of visceral metastases, presence and number of other bone metastases, functional status according to Karnofsky (Annex 1), neurological picture according to Frankel's scale (Annex 2) , pain assessed according to the Visual Analogue Scale (VAS), EuroQoL-5D and SF-36 questionnaires on the quality of life;
* information on the intervention: access, type of surgical treatment, possible preoperative embolization; intraoperative complications;
* information at discharge: postoperative complications, pain, neurological picture, functional status;
* follow-up data: pain (VAS scale), neurological picture (according to the Frankel scale), functional status according to Karnofsky, EuroQoL-5D and SF-36 questionnaires on quality of life, late complications, local recurrence; systemic progression of the disease.

The clinical data necessary for the research will be extracted from the patient's medical record and from its source documents.

A specific data collection form will be used to collect the clinical information and the results of the analysis foreseen by the study.

For each patient included in the study, the data collection form (Case Report Form - CRF) will be compiled.

Follow-up checks will be performed, as per clinical practice, at 3 months, 6 months, 12 months, 18 months, 24 months and 36 months.

Prospective Observational Study on Vertebral Metastasis

Prospective Observational Study on Patients Treated for Vertebral Metastasis and Vertebral Localizations of Lymphoproliferative Disease: Impact of the Treatment on the Quality of Life.

Visual Analogue Scale (VAS) patient-administered questionnaire

EuroQoL- 5D (EQ-5D) patient-administered questionnaire

Short Form Health Survey 36 (SF-36) patient-administered questionnaire

Surgery-related adverse events collected by SAVES-v.2 system

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
SPINERY™ A Novel Radio-Frequency Tumor Ablation Device Study	NCT05467540	Vertebral Metas...	SPINERY	18 Years -	Axon srl
Multicentre Medical-economic Study Evaluating the Efficacy of Adding ZOlédronique Acid to STERéotaxique Radiotherapy in the Treatment of Vertebral Metastases	NCT03951493	Vertebral Metas...	Zoledronic Acid... Hypo-fractured ...	18 Years -	Institut Cancerologie de l'Ouest
Phase II Trial of Stereotactic Radiation Therapy (SRT) Versus SRT Plus Vertebral Augmentation Procedure (VAP) for Vertebral Metastasis	NCT01527292	Vertebral Metas...	Stereotactic Ra... SRT with Verteb...	18 Years -	University of Louisville
Multicentre Medical-economic Study Evaluating the Efficacy of Adding ZOlédronique Acid to STERéotaxique Radiotherapy in the Treatment of Vertebral Metastases	NCT03951493	Vertebral Metas...	Zoledronic Acid... Hypo-fractured ...	18 Years -	Institut Cancerologie de l'Ouest
Phase II Trial of Stereotactic Radiation Therapy (SRT) Versus SRT Plus Vertebral Augmentation Procedure (VAP) for Vertebral Metastasis	NCT01527292	Vertebral Metas...	Stereotactic Ra... SRT with Verteb...	18 Years -	University of Louisville
Conformal High Dose Intensity Modulated Radiation Therapy for Disease to Thoracic and Lumbar Spine	NCT01654068	Vertebral Metas...	Conformal High ...	18 Years -	University of Kentucky
SPINERY™ A Novel Radio-Frequency Tumor Ablation Device Study	NCT05467540	Vertebral Metas...	SPINERY	18 Years -	Axon srl
Potential Vertebroplasty Use in the Treatment of Vertebral Metastasis From Breast and Prostate Cancer	NCT00294151	Breast Cancer Prostate Cancer Vertebral Metas... Pain	Vertebroplasty	35 Years - 75 Years	McGill University Health Centre/Research Institute of the McGill University Health Centre
Prospective Observational Study on Vertebral Metastasis	NCT05985434	Vertebral Metas...	Surgical treatm...	18 Years -	Istituto Ortopedico Rizzoli

Spots Global Cancer Trial Database for vertebral metastasis