SBRT for Stereotactic Body Radiation Therapy

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Wisconsin, Madison, WI
Stereotactic Body Radiation Therapy+4 More
SBRT - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

OAR-Based, Dose Escalated SBRT With Real Time Adaptive MRI Guidance for Liver Metastases

See full description

Eligible Conditions

  • Stereotactic Body Radiation Therapy
  • MRI-guided Treatment
  • Hepatic Metastases

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether SBRT will improve 1 primary outcome and 3 secondary outcomes in patients with Stereotactic Body Radiation Therapy. Measurement will happen over the course of Up to 4 weeks.

Up to 4 weeks
Number of Participants with Acute Dose Limiting Toxicity (DLT)
Up to 5 years
Overall Survival (OS)
Progression Free Survival (PFS)
up to 1 year
Local Control Rates

Trial Safety

Safety Progress

1 of 3

Side Effects for

Nivolumab/Ipilimumab Plus SBRT
Fatigue
100%
Diarrhea
56%
Hypothyroidism
32%
Rash
32%
Amylase
24%
Pruritus
24%
Lipase
24%
Adrenal Insufficiency
16%
ALT
12%
Hyperthyroidism
12%
AST
12%
Radiation Pneumonitis
8%
Arthritis
8%
Pneumonitis
8%
Colitis
4%
Creatinine
4%
AST (Aspartate transaminase)
4%
ALT (Alanine Transaminase)
4%
Hypophysitis
4%
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT03065179) in the Nivolumab/Ipilimumab Plus SBRT ARM group. Side effects include: Fatigue with 100%, Diarrhea with 56%, Hypothyroidism with 32%, Rash with 32%, Amylase with 24%.

Trial Design

1 Treatment Group

MRI-Guided SBRT Dose Escalation
1 of 1
Experimental Treatment

This trial requires 48 total participants across 1 different treatment group

This trial involves a single treatment. SBRT is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

MRI-Guided SBRT Dose Escalation
Radiation
Treatment on MRI Linac with SBRT in 5 fractions with adaptive planning, maximum dose 80 Gy Dose Escalation Bowel Pathway, V34 < 0.5cc Dose Escalation Liver Pathway, 700 cc < 16 Gy Subsequent Phase 1B: CRC only for Safety and Local Control, dosage informed by Phase 1A
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SBRT
2013
Completed Phase 2
~550

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 5 years for reporting.

Closest Location

University of Wisconsin - Madison, WI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Stereotactic Body Radiation Therapy or one of the other 4 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
For Phase IA trial, have a diagnosis of histologically confirmed or clinically suspected metastatic cancer to the liver; for Phase IB trial have have a diagnosis of histologically confirmed or clinically suspected metastatic CRC to the liver.
Participant must be a candidate for SBRT to at least one intrahepatic lesion but no more than 6 intrahepatic lesions.
Participant must be a candidate for treatment on the ViewRay treatment unit. Must be screened to rule out implants and devices that are not MRI compatible.
Be willing and able to provide written informed consent.
Participants may be therapy-naïve or have had prior systemic therapy up to two weeks prior to study entry.
At least 28 days from prior definitive treatment of their CNS disease by surgical resection, SBRT or Whole Brain Radiation Therapy (WBRT) at the time of registration
AND asymptomatic and off systemic corticosteroids and/or enzyme-inducing antiepileptic medications for brain metastases for >14 days prior to registration.
Demonstrate adequate organ function as defined in the following table; all screening labs should be performed within 28 days of SBRT treatment initiation.
Platelet count greater than or equal to 50000 /µL
Absolute Neutrophil Count (ANC) greater than or equal to 1000 /µL

Patient Q&A Section

What does sbrt usually treat?

"Sbt-related diseases are frequent in clinical practice. The reported data reveal that liver tumors occur in a significant percentage of Sbt-treated patients, and therefore deserve recognition for this drug. Sbt could play an active role in the management of these patients." - Anonymous Online Contributor

Unverified Answer

What causes liver neoplasms?

"Liver neoplasias frequently originate in the cirrhotic liver and are sometimes a sign of underlying hepatitis B/C. The role of other possible factors, such as chronic pancreatitis, drug-induced liver injury, or certain dietary (hepatic) factors, is less firmly established. The liver of patients who develop liver tumors may be defective because of damage from alcohol, viral infection, or other physical factors. Liver cancer in the West is primarily caused by infection with hepatitis B. A hepatitis C co-infection is associated with the development of liver cancer." - Anonymous Online Contributor

Unverified Answer

Can liver neoplasms be cured?

"Liver neoplasms will never be cured. However, they can be greatly reduced in certain cases, and this can be achieved through many different modalities, such as radical surgery, radiofrequency ablation, radiofrequency ablation combined with embolization and interferon." - Anonymous Online Contributor

Unverified Answer

What is liver neoplasms?

"Liver neoplasms are benign, non-cancerous masses that are found in 5% of patients who suffer from liver disorders. Usually, liver tumors have an indolent course, and there is no evidence of malignancy, including the presence of cancer cells, in benign lesions. Nevertheless, patients should be encouraged to take periodic liver checkups and to undertake the most appropriate diagnostic methods. The most common benign tumors are lipoma, hamartoma, hemangiomas, focal nodular hyperplasia, and hepatocellular adenoma. They pose no major problems or complications and there is no need to undergo urgent intervention." - Anonymous Online Contributor

Unverified Answer

What are common treatments for liver neoplasms?

"Generally, benign liver tumors are treated via conservative or focal therapies, while the treatment of malignant liver tumors is often palliative due to the advanced stage of disease. Radical surgery, radiation, and chemoembolization are common treatment methods, while some patients may benefit from hepatocellular transplantation." - Anonymous Online Contributor

Unverified Answer

What are the signs of liver neoplasms?

"In patients with unexplained encephalopathy, a high incidence of liver neoplasms (6.4%) was found. For patients who presented with nonspecific symptoms, liver lesions and a positive laboratory workup were more frequent. More patients with liver lesions required liver transplantation. Liver biopsy was more frequent in the presence of systemic and nutritional complications and liver enzyme values and was predictive of liver lesions." - Anonymous Online Contributor

Unverified Answer

How many people get liver neoplasms a year in the United States?

"The incidence and mortality rates of liver cancer are rising in women. The higher incidence of liver cancer in U.S. women must be carefully investigated to evaluate risk factors that might be associated with increased risk for liver cancer." - Anonymous Online Contributor

Unverified Answer

How quickly does liver neoplasms spread?

"Liver neoplasms have the ability to spread and therefore the metastatic behavior of these tumors depends on the type of growth form, presence or absence of capsule, and size of the tumor. The metastatic behavior was determined by the following parameters: the degree of differentiation, the presence or absence of neoplastic capsule, and the presence of vascular invasion." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving sbrt?

"sbrt may be an effective immunotherapy for HCC. It is very promising that the combination strategy of Sbrt with PD-1 inhibition represents a promising anti-cancer therapeutic immunotheraputic treatment in HCC patients." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing liver neoplasms?

"Lifestyle risk factors seem to decrease the risk of developing liver neoplasms, but they cannot compensate entirely for genetic and familial risk factors. Patients who are asymptomatic have higher risks of liver neoplasms developing." - Anonymous Online Contributor

Unverified Answer

What is the latest research for liver neoplasms?

"The current treatments were only palliative and do not provide durable survival or quality of life for patients. New treatments to combat liver carcinogenesis are urgently needed, and a combination therapy with chemotherapy and antiangiogenic drugs represents a new alternative for treatment. TACE is a novel therapy option that has shown good and predictable results on the short term in a short number of cases. There is also evidence suggesting that TACE may have less severe effects in liver carcinogenesis, which could be more clinically relevant in patients with comorbidities. Longer studies, with larger sample sizes, are necessary to assess the clinical effectiveness of TACE as a novel anti-neoplasm therapy in patients with liver malignancies." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating liver neoplasms?

"Recent advances in chemotherapy and surgery have greatly improved the survival of patients with [liver cancer](https://www.withpower.com/clinical-trials/liver-cancer), and liver disease has received far less attention than that of other types of cancer. We need to acknowledge these realities so that better treatment plans may be devised for all patients with liver cancer, not just those at the forefront of current medical science." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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