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Radiation Therapy

Stereotactic Body Radiation Therapy for Liver Cancer

Q: Is this investigation enlisting participants presently?

<p>The official records from clinicaltrials.gov state that this research study is open for participants and has been since February 7th 2019. The trial was most recently amended on September 22nd 2022.</p>

Q: How many test subjects are involved in this experiment?

<p>Affirmative, according to clinicaltrials.gov this research is actively recruiting eligible participants. It was originally posted on February 7th 2019 and the latest update occurred on September 22nd 2022. For now, they are targeting 15 individuals from a single site.</p>

N/A

Waitlist Available

Led By Nima Nabavizadeh, MD

Research Sponsored by OHSU Knight Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Clinical Oncology Group (ECOG) performance status =< 2, or Karnofsky performance scale > 60

Safe radiation treatment planning parameters that adhere to all organs at risk constraints per section 5.1 of the protocol. If normal organs at risk constraints (including at least 700cc of uninvolved liver) are unable to be met at the lowest dose modification (30 Gy in 5 fractions), the patient is deemed ineligible for SBRT and deemed a screen failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 months after last sbrt dose

Awards & highlights

Study Summary

This trial is testing how well stereotactic body radiation therapy works to treat patients with liver cancer.

Who is the study for?

This trial is for liver cancer patients who may be listed for a liver transplant, can consent to treatment, have moderate to severe liver impairment (CP score >= B8), and are in fair health or better (ECOG <=2). They must not be pregnant, have had certain other cancers recently, or have more than 5 liver tumors or any larger than 5 cm. People with serious illnesses that could affect the study are excluded.Check my eligibility

What is being tested?

The trial is testing Stereotactic Body Radiation Therapy (SBRT) on patients with liver cancer. SBRT precisely targets tumors with high-dose radiation aiming to destroy them while sparing healthy tissue. The study includes questionnaires and quality-of-life assessments to evaluate the therapy's effectiveness.See study design

What are the potential side effects?

Potential side effects of SBRT may include fatigue, skin reactions at the treatment site, nausea, changes in appetite, and abdominal pain. There might also be a risk of damage to nearby organs like the stomach or intestines due to radiation exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself but might not be able to do heavy physical work.

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My radiation treatment plan meets safety guidelines for protecting my organs.

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I am on or recommended to be on the liver transplant list.

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My liver function score is B8 or higher.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to time of progression, transplantation, death or 2-years after last sbrt dose, whichever occurs first

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to time of progression, transplantation, death or 2-years after last sbrt dose, whichever occurs first

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to time of progression, transplantation, death or 2-years after last sbrt dose, whichever occurs first for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of participants who are transplanted or with localized disease control per Milan criteria

Secondary outcome measures

Incidence of extrahepatic progressive disease

Incidence of intrahepatic progressive disease

Incidence of liver toxicity assessed per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0

+4 more

Other outcome measures

Change in QoL scores for Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire

Change in quality of life (QoL) score using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 questionnaire

Proportion of histopathologic changes in irradiated tumor sites relative to uninvolved liver tissue

Side effects data

From 2022 Phase 2 trial • 29 Patients • NCT02045446

79%

Cough

64%

Dyspnea

64%

Nausea

57%

Fatigue

43%

Constipation

36%

Pain

36%

Dizziness

29%

Anemia

29%

Back pain

29%

Vomiting

21%

Chest pain

21%

Anorexia

21%

Lymphocyte count decreased

21%

Death NOS

21%

Anxiety

21%

Fall

14%

Wheezing

14%

Dysphagia

14%

Hypotension

14%

Depression

14%

Diarrhea

14%

Platelet count decreased

14%

Abdominal Pain

14%

Edema

14%

Fever

14%

Headache

14%

Insomnia

14%

Palpitations

Alopecia

Creatinine increased

Dehydration

Otitis externa

Blurred vision

Sinusitis

Dysgeusia

Hemorrhoids

Amnesia

Confusion

Dementia

Productive cough

Pneumonitis

Dysuria

White blood cell count decreased

Throat pain

Bone marrow biopsy

Hearing impaired

Rash

Hypernatremia

Eye pain

Hypertension

Tachycardia

Lung infection

Neuropathy

Pleuritic pain

Neutropenia

Hypoxia

Aspiration pneumonia

Blood bilirubin increased

Muscle weakness

Tremor

Weight loss

Thrombocytopenia

Floaters

Toothache

Esophagitis

Leukocytosis

Edema limbs

Gait disturbance

Parathesia (tingling)

Edema face

COPD

100%

80%

60%

40%

20%

Study treatment Arm

Stereotactic Body Radiation Therapy

Maintenance Chemotherapy

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (SBRT)Experimental Treatment3 Interventions

Patients undergo SBRT on days 1, 3, 5, 7, and 9 in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~780

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

OHSU Knight Cancer InstituteLead Sponsor

230 Previous Clinical Trials

2,090,717 Total Patients Enrolled

1 Trials studying Liver Cancer

339 Patients Enrolled for Liver Cancer

Oregon Health and Science UniversityOTHER

973 Previous Clinical Trials

7,385,803 Total Patients Enrolled

1 Trials studying Liver Cancer

339 Patients Enrolled for Liver Cancer

Radiation Oncology InstituteUNKNOWN

1 Previous Clinical Trials

Media Library

Liver Cancer Research Study Groups: Treatment (SBRT)

Liver Cancer Clinical Trial 2023: Stereotactic Body Radiation Therapy Highlights & Side Effects. Trial Name: NCT03812289 — N/A

Stereotactic Body Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03812289 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this investigation enlisting participants presently?

"The official records from clinicaltrials.gov state that this research study is open for participants and has been since February 7th 2019. The trial was most recently amended on September 22nd 2022."

Answered by AI

How many test subjects are involved in this experiment?

"Affirmative, according to clinicaltrials.gov this research is actively recruiting eligible participants. It was originally posted on February 7th 2019 and the latest update occurred on September 22nd 2022. For now, they are targeting 15 individuals from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer

Nima Nabavizadeh 2019. "Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03812289.