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Radiation Therapy

Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma

Phase 3

Waitlist Available

Led By Daniel Chang, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up randomization through 3 years

Awards & highlights

Study Summary

This trial is comparing the effectiveness of transarterial chemoembolization (TACE), stereotactic body radiation therapy (SBRT), and stereotactic ablative radiation therapy (SABR) in treating patients with liver cancer.

Eligible Conditions

Hepatocellular Carcinoma
Child-Pugh

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ randomization through 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~randomization through 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization through 3 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Number of Participants With a Local Progression Event

Secondary outcome measures

Comparison of Median Freedom From Extra Hepatic Progression

Median Extra Hepatic PFS for Patients With Tumors Smaller Than 3 cm and Greater Than 3 cm Per Treatment Group

Median FFLP for Patients With Tumors Smaller Than 3 cm and With Tumors Greater Than 3 cm Per Treatment Group

+8 more

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

Dehydration

Creatinine increased

Otitis externa

Sinusitis

Dysgeusia

Hemorrhoids

Amnesia

Confusion

Dementia

Productive cough

Pneumonitis

Dysuria

White blood cell count decreased

Throat pain

Bone marrow biopsy

Blurred vision

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

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (SBRT)Experimental Treatment1 Intervention

Beginning within 2 weeks of the radiation set-up scan and within 4 weeks of fiducial seed implantation (if applicable), patients undergo image guided SBRT 3 fractions within 1 week or 5 fractions within 2 weeks.

Group II: Arm I (TACE)Active Control3 Interventions

Patients undergo TACE.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~780

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,394 Previous Clinical Trials

17,341,597 Total Patients Enrolled

7 Trials studying Hepatocellular Carcinoma

396 Patients Enrolled for Hepatocellular Carcinoma

National Cancer Institute (NCI)NIH

13,662 Previous Clinical Trials

40,925,868 Total Patients Enrolled

44 Trials studying Hepatocellular Carcinoma

6,310 Patients Enrolled for Hepatocellular Carcinoma

Daniel Chang, MDPrincipal InvestigatorStanford University

2 Previous Clinical Trials

30 Total Patients Enrolled

Frequently Asked Questions

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

Are there any other patients who can still join this research project?

"Unfortunately, this particular clinical trial has already wrapped up recruitment. Although, according to the latest update on September 9th, 2022, there are still 3508 other trials searching for patients and 6 of those admit participants that have received Stereotactic Body Radiation Therapy."

Answered by AI

Could you please elaborate on the side effects of Stereotactic Body Radiation Therapy?

"There is some evidence to support the efficacy of Stereotactic Body Radiation Therapy, as this therapy has reached Phase 3 clinical trials. Furthermore, data collected thus far also suggests that this treatment option is safe, warranting a score of 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Transarterial Chemoembolization Compared With Stereotactic Body Radiation Therapy or Stereotactic Ablative Radiation Therapy in Treating Patients With Residual or Recurrent Liver Cancer Undergone Initial Transarterial Chemoembolization

Erqi Liu Pollom 2016. "Transarterial Chemoembolization Compared With Stereotactic Body Radiation Therapy or Stereotactic Ablative Radiation Therapy in Treating Patients With Residual or Recurrent Liver Cancer Undergone Initial Transarterial Chemoembolization". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02762266.