Neoplasms

Symptoms and General Pathology

All Conditions

Musculoskeletal Diseases

Blood and Lymph Conditions

Neoplasm Metastasis

Pain

Bone Neoplasms

Bone Marrow Diseases

Neoplastic Processes

Bone Diseases

Hematologic Diseases

FLASH radiotherapy is radiation treatment delivered at ultra-high dose rates compared to conventional radiation treatment.

A dose of 8 Gy delivered in a single fraction will be prescribed to the PTV, delivered with FLASH Radiotherapy (\>40 Gy/s).

FLASH Radiotherapy

Jennifer Woo

Stefanie Parker

Cincinnati Children's Hospital Medical Center-Cancer Line

John Breneman, MD

Emily Daugherty, MD

John Perentesis, MD

The purpose of this study is to assess toxicities of FLASH radiotherapy treatment and pain relief in subjects with painful thoracic bone metastases. FLASH radiotherapy is radiation treatment delivered at ultra-high dose rates compared to conventional radiation treatment.

This clinical investigation is designed to assess the toxicities of FLASH radiotherapy treatment, as well as pain relief when used to treat bone metastasis(-es) in the thorax. Workflow metrics of FLASH radiotherapy in the thorax in a clinical setting will also be assessed. Patients at least 18 years of age with painful bone metastases located in the thorax will be considered for the study. Eligible subjects will be treated for painful bone metastases in the thorax using a palliative regimen of FLASH radiotherapy and followed post-treatment until subject death or lost to follow-up.

FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases in the Thorax

Toxicities that are possibly, probably, or definitely related to FLASH radiotherapy. Toxicities will be classified per CTCAE version 5.0.

Capture dose and frequency of pain medication usage or pain medication changes.

Treatment for an individual subject will be deemed NOT feasible if delays in study treatment of more than 10 business days from simulation to treatment occurs related to the investigational device (excluding delays due to patient or facility factors not related to study treatment).

Varian, a Siemens Healthineers Company

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Behaviors and Mental Disorders

Rare Diseases

Carcinoma

Breast Neoplasms

Melanoma

Prostatic Neoplasms

Carcinoma, Renal Cell

Urogenital Neoplasms

Urogenital Diseases

Male Urogenital Diseases

Neoplasms by Histologic Type

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Kidney Neoplasms

Urologic Neoplasms

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Quality of Life

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Patients will received a single fraction of 15-20 Gy to bone metastases causing pain. Planning and delivery will be conducted using a volumetric modulated arc therapy (VMAT) approach on the Varian TrueBeam platform. Patients will be CT simulated, with vac-lock immobilization. Use of 4-dimensional CT will be dependent on the area being treated. Daily image guidance will be performed using cone beam CT aligning to relevant bony anatomy.

SBRT

Stephan Tran, MD

Eric K Nguyen, MD

Anand Swaminath, MD

Radiation therapy has been shown to be very effective at relieving pain caused by bone metastases. However, certain types of cancers such as prostate, breast, kidney, and melanoma can have resistance to radiation, making treatment less successful. Stereotactic body radiotherapy (SBRT) is a newer form of focused treatment that gives higher doses of radiation without damage to surrounding organs. It often is used to help control and cure disease, but less commonly as a way to palliate and treat symptoms. This study is looking at using SBRT for the purposes of improving pain caused by bone metastases in prostate cancer, breast cancer, kidney cancer, and melanoma patients. It is theorized that the higher levels of radiation may be able to combat the resistance some tumour cells have to radiotherapy and provide improved pain response to treatment. The investigators are looking to show that SBRT has a role in helping this group of patients deal with painful bone lesions from their cancer without increasing side effects and toxicity from the radiation treatment.

Stereotactic body radiotherapy (SBRT) has shown promising early results in the management of bone metastases. However, there is a paucity of prospective data studying the use of SBRT for bone metastases originating from low alpha-beta tumors, with systematic reporting of changes in pain scores and analgesia use over time. The vast majority data looking at SBRT in bone lesions focuses on local control and survival, rather than more tangible outcomes in a palliative population including symptomatic control, durability of response, and patient reported quality of life; a component that is understudied in this group despite its tremendous value. Furthermore, SBRT for bone metastases has yet to become common practice given the limited evidence for its efficacy and uncertainty in regards to toxicity.

The current study proposes an investigation of the potential benefits of SBRT for symptomatic bone metastases in patients with prostate cancer, breast cancer, renal cell carcinoma, melanoma, and sarcoma. The investigators look to conduct a prospective cohort study that is adequately powered to analyse efficacy in alleviating pain from bone lesions and compare this to well-established rates in literature for conventionally fractionated palliative RT. Furthermore, this study will assess the tolerability of this modality, toxicity rates, and effect on quality of life. If the results show that SBRT has a significant benefit on this population, the goal would be to pursue a larger randomized trial to confirm the findings.

Stereotactic Body Radiotherapy for Osseous Low Alpha-Beta Resistant Metastases for Pain Relief

According to the Common Terminology Criteria for Adverse Events 5.0

Assessed by EORTC quality of life questionnaires

Due to instability or symptomatic progression

Juravinski Cancer Centre Foundation

Hamilton Health Sciences Corporation

This purpose of this study is to assess the feasibility of FLASH radiotherapy for the palliative treatment of painful bone metastases. FLASH radiotherapy is radiation treatment delivered at ultra-high dose rates compared to conventional radiation treatment.

This clinical investigation is designed to assess the workflow feasibility of FLASH radiotherapy treatment in a clinical setting, as well as the toxicities, and pain relief when used to treat bone metastasis(-es) in the extremities (excluding feet, hands, wrists). FLASH radiotherapy has been shown in preclinical studies to cause less injury to surrounding normal tissues during radiation treatment, while still having similar tumor cell killing. Patients at least 18 years of age with painful bone metastases located in the limbs will be considered for the study. These patients represent an ideal population for a feasibility study of FLASH radiotherapy as they are known to benefit from the palliative effects of radiotherapy using single dose radiation regimens of 8Gy which is what is being used in this investigation. After treatment, patients will be assessed for pain response as well as any adverse side-effects of radiation. The workflow feasibility of the treatment will also be evaluated.

Open label, single arm prospective feasibility study

Feasibility Study of FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases

Treatment for an individual subject will be deemed NOT feasible if total treatment time on table is greater than one hour .

Treatment for an individual subject will be deemed NOT feasible if delays in study treatment of more than 7 business days from simulation to treatment occurs related to the investigational device (excluding delays due to patient or facility factors not related to study treatment)

Patient reported pain score overall and specifically for treated sites.

Digestive System Diseases

Stomach Neoplasms

Adenoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Dexamethasone

Sucralfate

Dexamethasone acetate

Lansoprazole

Dexlansoprazole

Proton Pump Inhibitors

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

To receive intravenous dexamethasone (0.15 mg/kg) immediately after ESD

To receive normal saline as placebo intravenous immediately after ESD

Patients were enrolled in outpatient settings after evaluating appropriate ESD indications. A single study coordinator performed a randomization process by using a table of random numbers. The patients were allocated to receive intravenous dexamethasone (0.15 mg/kg) immediately after ESD. The patients with an odd number were assigned into DEXA group, and the patients with an even number were assigned into placebo group. The syringe including dexamethasone was completely covered with a paper sticker to mask treatment assignment. The operator and assisting nurse were also blinded to the study.

At the day and next day of ESD, intravenous proton pump inhibitor was routinely administered to prevent complications including bleeding. At 3rd day of ESD, all patients started to take 40mg oral lansoprazole once a day and sucralfate suspension 3 times a day for 28 days.

intravenous dexamethasone

Patients were enrolled in outpatient settings after evaluating appropriate ESD indications. A single study coordinator performed a randomization process by using a table of random numbers. The patients were allocated to receive intravenous normal saline as placebo immediately after ESD. The patients with an odd number were assigned into DEXA group, and the patients with an even number were assigned into placebo group. The syringe including placebo was completely covered with a paper sticker to mask treatment assignment. The operator and assisting nurse were also blinded to the study.

At the day and next day of ESD, intravenous proton pump inhibitor was routinely administered to prevent complications including bleeding. At 3rd day of ESD, all patients started to take 40mg oral lansoprazole once a day and sucralfate suspension 3 times a day for 28 days.

intravenous normal saline

Hyuk Lee, MD

Besides major ESD-related complications, minor adverse events after ESD are also commonly noticed. Pain is one of minor ESD-related complications. . The causes of pain associated with ESD or gastric polypectomy are thought to be associated with transmural burn or transmural air leak. How control localized pain for patients who suffered from pain after ESD is appearing as new medical interests. There are few studies about management strategy for pain after ESD. Glucocorticoids are used to reduce inflammation and tissue damage in various clinical settings including inflammatory disease, rheumatic disease, and so on. The efficacy of glucocorticoids for reducing pain after surgery has recently been investigated. Glucocorticoids are thought to locally inhibit collagen deposition and fibrosis and finally reduce scar-tissue formation. Especially systemic steroids are easy to achieve a continuous effect through stable serum concentrations. If pain was partially associated with acute inflammation, we assumed intravenous dexamethasone could be helpful to relieve pain after ESD based on previous studies. we aimed to assess the efficacy of single dose postoperative intravenous dexamethasone for pain relief after ESD.

Pilot Trial on Efficacy of Single Dose Perioperative Intravenous Dexamethasone for Pain Relief After Endoscopic Submucosal Dissection

The primary outcomes of this study was present pain intensity (PPI) measured at 6 hours after ESD. The reason for adopting 6- hour PPI as primary endpoint was due to maximized pain at 6 hours after ESD in our pilot study.

Yonsei University

Neoplasms, Second Primary

4 Gy single fraction; mandate first retreatment if moderate or severe pain persists or recurs (as measured by categorical pain scale or VAS greater than 50 mm), \>4 weeks after initial RT) retreat with 8 Gy single fraction; second retreatment is optional if moderate or severe pain recurs (as measured by categorical pain scale or VAS greater than 50 mm), retreat with 8 Gy after \> 4 weeks

8 Gy single fraction, mandate first retreatment if moderate or severe pain persists or recurs (as measured by categorical pain scale or VAS greater than 50 mm), \>4 weeks after initial RT) retreat with 8 Gy single fraction; second retreatment is optional if moderate or severe pain recurs (as measured by categorical pain scale or VAS greater than 50 mm), retreat with 8 Gy after \> 4 weeks

8 Gy in a single fraction; retreatments \> 4 weeks, using local RT fields to sites of residual or recurrent, moderate or severe pain with a single fraction of 8 Gy) ; second reirradiation with 8 Gy using local RT fields optional (at discretion of PI);

12 Gy in 4 fractions of 3 Gy in 2 consecutive days interfraction interval of a minimum of 6 hrs; retreatments \> 4 weeks using local RT fields to sites of residual or recurrent, moderate or severe pain with a single fraction of 8 Gy); second reirradiation with 8 Gy using local RT fields optional (at discretion of PI) ;

Radiotherapy

Elena Fidarova, MD

Bone metastasis is one of the most frequent end complications of the cancer. Radiation therapy is the mainstay of treatment in this disease. Single fraction radiotherapy in both single and multiple bone metastasis is widely used, but optimization of the single dose fractionation is needed. Two different regimens of radiotherapy dose fractionation will be investigated in both single and multiple bone metastasis and endpoints will include pain relief as well as toxicity and quality of life.

PROTOCOL SCHEMA

Group A Treatment of single site of painful bone metastasis:

Arm 1: 4 Gy single fraction; mandate first retreatment if moderate or severe pain persists or recurs (as measured by categorical pain scale or VAS greater than 50 mm), \>4 weeks after initial RT) retreat with 8 Gy single fraction; second retreatment is optional if moderate or severe pain recurs (as measured by categorical pain scale or VAS greater than 50 mm), retreat with 8 Gy after \> 4 weeks

Arm 2: 8 Gy single fraction, mandate first retreatment if moderate or severe pain persists or recurs (as measured by categorical pain scale or VAS greater than 50 mm), \>4 weeks after initial RT) retreat with 8 Gy single fraction; second retreatment is optional if moderate or severe pain recurs (as measured by categorical pain scale or VAS greater than 50 mm), retreat with 8 Gy after \> 4 weeks

Group B Treatment of multiple bone metastasis: lower hemibody radiotherapy (LHBI):

Arm 3: 8 Gy in a single fraction; retreatments \> 4 weeks, using local RT fields to sites of residual or recurrent, moderate or severe pain with a single fraction of 8 Gy) ; second reirradiation with 8 Gy using local RT fields optional (at discretion of PI);

Arm 4: 12 Gy in 4 fractions of 3 Gy in 2 consecutive days interfraction interval of a minimum of 6 hrs; retreatments \> 4 weeks using local RT fields to sites of residual or recurrent, moderate or severe pain with a single fraction of 8 Gy); second reirradiation with 8 Gy using local RT fields optional (at discretion of PI) ;

Optimization of Radiotherapy in Treatment of Painful Bone Metastasis

Investigation of Optimal Radiotherapy Regimen and Type of Irradiation in Treatment of Painful Bone Metastasis

International Atomic Energy Agency

Nutritional and Metabolic Diseases

Nervous System Diseases

Cancer Pain

Celiac Disease

Neurologic Manifestations

Central Nervous System Depressants

Anti-Infective Agents

Bupivacaine

Ethanol

Endoscopic Ultrasound Guided Coeliac Plexus Block

Endoscopic Ultrasound Guided Coeliac Plexus Radiofrequency Ablation

Chemical ablation is performed by injection of 10 mL of 0.25% bupivacaine, followed by 10 mL of 98% dehydrated alcohol using a 22G FNA needle (Cook and Olympus)

Alcohol injection

coeliac plexus is identified and punctured with 19G EUSRA RFA needle with 10W-30W of energy for 10-50s bilaterally or unilaterally depends on individual anatomical characteristics.

Radiofrequency Ablation

Wan Yee Chiu, BISC

Ka Wing Ma, MBBS, MS

Many cancer patients suffer from intractable pain and which is often suboptimally controlled by even strong opioid analgesics. Coeliac plexus neurolysis (CPN) is procedure which intended to permanently destroy the nociceptive pathway that transmits the pain caused by the tumour. It can be with different approaches, such as percutaneously guided by fluoroscopy, echo-endoscopically or surgically with endoscopic approach being the more popular one in many centers equipped with echo-endoscopic services. The effect of CPN has been well established by some retrospective series. The overall response rate to CPN ranges from 70-90%, however, the analgesic effect is limited and up to roughly around 3 months. It is believed that the short-lasting analgesic effect is related to incomplete neurolysis by absolute alcohol injection.

Recently, radiofrequency ablation (RFA) of coeliac plexus has been introduced as another mode of CPN. So far, only one small single center randomized controlled trial (RCT) suggesting superior performance in favour to CPN using RFA. This result has to be validated and by a RCT with larger sample size. In addition, data concerning the quality of life (QOL) improvement and cost-effectiveness need to be further elucidated. Therefore, the aim of this study is to perform a RCT to look into these issues.

The aim of this study is to compare the efficacy of EUS-CPN by chemical ablation using alcohol injection versus by radiofrequency ablation in patients with cancer pain related to intra-abdominal malignancy. This is a randomised controlled trial to assess the clinical outcomes and cost-effectiveness of this new treatment approach.

Endoscopic Ultrasound Guided Coeliac Plexus Neurolysis for Cancer Pain

Endoscopic Ultrasound-Guided Coeliac Plexus Neurolysis for Cancer Pain: Chemical Versus Radiofrequency Ablation

change of pain score at 4th week after the procedure (by VAS score)

change of pain score (Visual Analog Score) after the procedure

decrease in pain level by 30% from the pre-procedural baseline

time from injection of pre-medication to procedure last observation recording at the procedure suite

The University of Hong Kong

Clinical Assistant Professor

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Pain, Intractable

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Anti-Infective Agents, Local

Radiofrequency ablation of the coeliac plexus

* coeliac plexus is identified and punctured
* Injection of 10 mL of .25% bupivacaine, followed by 10 mL of 98% dehydrated alcohol.

98% dehydrated alcohol

* 10W-30W RFA will be applied unilaterally or bilaterally depends on individual anatomical characteristics for 10-50s
* Complete ablation of coeliac plexus nervous tissue is confirmed by appearance of air-bubble ultrasound scan

19G EUSRA needle, Taewoong Medical, Korea

The aim of this study is to compare the efficacy of EUS-guided CPN versus radiofrequency ablation in patients with pain related to pancreatic cancer. By performing a randomized controlled trial, the clinical outcomes and cost-effectiveness of this new RFA treatment approach can be evaluated.

EUS-Coeliac Plexus Block Versus Radiofrequency Ablation in Pain Relief of Patients With Malignancy

Endoscopic Ultrasound Guided Coeliac Plexus Block Versus Radiofrequency Ablation in Pain Relief of Patients With Intractable Pain Due to Malignancy A Randomized Controlled Study

Pain score at 4 weeks after procedure (by VAS score)

Decrease of pain level by 30% from pre-procedural baseline

Time from injection of pre-medication to procedure last observation recording at the procedure suite

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases in the Thorax	NCT05524064	Bone Metastases...	FLASH Radiother...	18 Years -	Varian, a Siemens Healthineers Company
Stereotactic Body Radiotherapy for Osseous Low Alpha-Beta Resistant Metastases for Pain Relief	NCT04177056	Bone Metastases Prostate Cancer Breast Cancer Renal Cell Carc... Melanoma	SBRT	18 Years -	Hamilton Health Sciences Corporation
Feasibility Study of FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases	NCT04592887	Bone Metastasis	FLASH Radiother...	18 Years -	Varian, a Siemens Healthineers Company
Pilot Trial on Efficacy of Single Dose Perioperative Intravenous Dexamethasone for Pain Relief After Endoscopic Submucosal Dissection	NCT02037399	Early Gastric C...	intravenous dex... intravenous nor...	20 Years - 80 Years	Yonsei University
Optimization of Radiotherapy in Treatment of Painful Bone Metastasis	NCT00610272	Pain Bone Metastasis	Radiotherapy Radiotherapy Radiotherapy Radiotherapy	18 Years -	International Atomic Energy Agency
Endoscopic Ultrasound Guided Coeliac Plexus Neurolysis for Cancer Pain	NCT04801082	Malignancy Pain Management	Alcohol injecti... Radiofrequency ...	18 Years -	The University of Hong Kong
EUS-Coeliac Plexus Block Versus Radiofrequency Ablation in Pain Relief of Patients With Malignancy	NCT04809935	Cancer of Pancr... Pancreatic Neop... Pain Cancer-Associat... Pain Management	98% dehydrated ... 19G EUSRA needl...	18 Years -	The University of Hong Kong
EUS-Coeliac Plexus Block Versus Radiofrequency Ablation in Pain Relief of Patients With Malignancy	NCT04809935	Cancer of Pancr... Pancreatic Neop... Pain Cancer-Associat... Pain Management	98% dehydrated ... 19G EUSRA needl...	18 Years -	The University of Hong Kong
Feasibility Study of FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases	NCT04592887	Bone Metastasis	FLASH Radiother...	18 Years -	Varian, a Siemens Healthineers Company

Spots Global Cancer Trial Database for pain relief

Every month we try and update this database with for pain relief cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pain relief

Every month we try and update this database with for pain relief cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pain relief cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.