Hepatocellular Carcinoma Using Stereotactic Body Radiotherapy

NCT01850316 | Unknown

• 1 other identifier: H13-00481
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Respiratory-gated, volumetric-modulated arc therapy will be used for the clinical development of high dose rate Stereotactic Body Radiotherapy (SBRT) in inoperable hepatocellular carcinoma (HCC). These treatments should enhance local control, progression-free survival and potentially overall survival in HCC patients. The investigators will also examine the mechanism of tumour and microenvironmental response to high dose radiation, and search for potential biomarkers to optimize and individualize therapy. Pre-treatment and follow-up PET/CT imaging with 11C-choline, 18F-fluorodeoxyglucose (FDG) and CT perfusion will examine in-vivo changes in proliferation, glycolysis, and the tumour vasculature, respectively, and blood samples will look for immunologic biomarkers of tumour response.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• One year local progression-free rate

  Approximately 1 year

Secondary Outcomes (6)

• Progression-free survival

  To be reviewed in approximately 8 years; upon study completion

• Overall Survival

  To be reviewed in approximately 8 years; upon study completion

• Treatment related toxicity

  To be reviewed in approximately 8 years; upon study completion

• Quality of Life

  To be reviewed in approximately 8 years; upon study completion

• Cytokine response to radiation and association with complications

  To be reviewed in approximately 8 years; upon study completion

Study Arms (1)

Stereotactic Ablative Radiotherapy

EXPERIMENTAL

Preferred target coverage of 40 Gy: coverage and total dose determined by irradiated liver volume NTCP (normal tissue complication probability) nomogram and OAR dose limits

Radiation: Stereotactic Ablative Radiotherapy

Interventions

Stereotactic Ablative Radiotherapy RADIATION

Preferred target coverage of 40 Gy: coverage and total dose determined by irradiated liver volume NTCP (normal tissue complication probability) nomogram and OAR dose limits

Stereotactic Ablative Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years old
• Multi-phase CT scan of the liver within 8 weeks of radiation planning demonstrating:
• Liver tumours must be \> 5 cm
• No more than 5 discrete liver tumours may be present
• Normal liver \> 700 cc
• FDG-PET scan within 12 weeks prior to radiation planning
• Patients must have HCC diagnosed by either: i) pathological confirmation, or ii) intrahepatic vascular enhancement of the lesion demonstrated by at least two imaging modalities, or iii) intrahepatic vascular enhancement of the lesion demonstrated by one imaging modality if AFP \> 200 in the setting of liver cirrhosis or chronic hepatitis B without cirrhosis (EASL consensus guidelines)
• Liver HCC must be deemed unresectable as determined by an experienced liver surgeon, or the patient must be medically inoperable or refuse surgery, and extra-hepatic metastases must not be present (Patients with potential resectable tumours who are deemed unresectable based on medical inoperability or simultaneous extra-hepatic metastases will be eligible to receive SBRT).
• Patients must be discussed in a multidisciplinary setting where opinions regarding radiofrequency ablation, various embolotherapies, and targeted biologics are considered, but not eligible for. Patients must have recovered from the effects of previous therapies before SBRT.
• Eastern Clinical Oncology Group performance status 0,1 or 2 or a Karnofsky performance status of ≥ 60
• Adequate organ function as assessed by the following blood work:
• Hemoglobin ≥ 90 g/L
• Absolute neutrophil count ≥ 1.0 bil/L
• Platelets ≥ 50 bil/L
• AST and ALT not to exceed 2x upper limit of normal

You may not qualify if:

• Patient signs a study-specific informed consent form. If the patient's mental status precludes this, written informed consent may be given by the patient's legal representative. A translator will be provided if the patient has a language barrier.
• Treatment plans meet acceptable dose constraints and Liver Veff is ≤ 0.55
• Patients with active hepatitis, encephalopathy, or ascites related to liver failure
• Female patients who are pregnant (verify with blood test if patient is pre-menopausal). Pre-menopausal patients may also not become pregnant during participation in this study.
• Prior external beam radiation to the upper abdomen
• Patients with distant metastases or extrahepatic nodal progression (patients with portal venous thrombosis and liver hilum nodal involvement remain eligible)
• Patients who have \< 700 cc of normal liver.
• Child-Turcotte-Pugh scores \> 7
• BCLC Stage A, C (N1 and/or M1), D
• Prior gastric, duodenal, or variceal bleed within the past 2 months

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (1)

BC Cancer Agency

Vancouver, British Columbia, V5Z4E6, Canada

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Roy Ma, MD

  British Columbia Cancer Agency

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2013
• First Posted: May 9, 2013
• Study Start: July 1, 2013
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2020
• Last Updated: January 18, 2018

Record last verified: 2018-01

Locations

CA (1)