Stereotactic Body Radiation Therapy (SBRT) Hepatocellular Carcinoma (COLD 2)

NCT00914355 | Completed Phase 2 DMC

• 1 other identifier: UHN REB 07-0346-C
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to see whether stereotactic body radiation therapy (SBRT) can reduce tumour size, slow progression of the disease, prolong life and improve quality of life of patients with hepatocellular carcinoma, a cancer of the liver, that cannot be removed surgically (unresectable) and cannot be treated with ablative therapy (e.g. radio-frequency ablation) or trans-arterial chemo-embolization (TACE) therapy (delivery of chemotherapy through an artery that feeds into the liver). SBRT is concentrated focused radiation therapy delivered very precisely to the liver tumour. It is hoped that knowledge obtained from this study will improve our ability to treat patients with liver tumours that cannot be treated with surgery and other methods, and that SBRT may prove to be a treatment that can lead to long-term and permanent control of liver tumours for some patients.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; Stereotactic Body Radiation; Unresectable liver cancer; Patients with Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Determine one year local progression free rate, defined as lack of progression within the irradiated volume, using RECIST criteria

  5 years

Secondary Outcomes (5)

• Overall progression free survival

  5 years

• Overall survival

  5 years

• Quality of life

  5 years

• CTC3.0 toxicity

  5 years

• Cytokine response to radiation and association with complications

  5 years

Study Arms (1)

SBRT for Hepatocellular Carcinoma

EXPERIMENTAL

Radiation: Stereotactic Body Radiation

Interventions

Stereotactic Body Radiation RADIATION

Radiation therapy will be delivered on six occasions, over two weeks. Each treatment will take approximately 30 minutes to deliver.You may be asked to swallow 250 cc of oral contrast before each radiation therapy treatment.Pepto Bismol (a liquid that coats the stomach and is used to treat heartburn) and/or water may be combined with the contrast to improve the quality of the stomach's image.

SBRT for Hepatocellular Carcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed pathologically, 2)diagnosed by showing vascular enhancement of the lesion on at least two imaging techniques, or 3) diagnosed by showing vascular enhancement on a single technique if the AFP is greater than 200, in the setting of cirrhosis or chronic hepatitis B without cirrhosis (EASL consensus conference guidelines).
• Either 1) the tumour must be unresectable, based on the opinion of an experienced surgeon specializing in hepatic resection, or 2) the patient Phase II SBRT HCC 13 must be medically inoperable, or 3) extra-hepatic metastases must be present (making hepatic surgery an inappropriate treatment option).
• Karnofsky performance status (KPS) \> 60 (Appendix II)
• Age: 18 years or older. Both male \& female patients of all races can be included in this study. Female patients within reproductive years may not be, nor become, pregnant during participation in this study
• Patients must have recovered from the effects of previous therapy.
• Maximal tumor size of 15 cm.
• Adequate organ function as assessed as follows:
• Hemoglobin \> 90 g/L
• Absolute neutrophil count \> 1.0 bil/L
• Platelets \> 50 bil/L
• Bilirubin \< 4.0 times upper range of normal
• INR \< 1.5 or correctable with vitamin K (unless patient is on coumadin in which case higher levels are acceptable)
• AST or ALT \< 6.0 times upper range of normal
• Child's A 5-6 liver score or Child B 7-8 liver score, which is only permitted if the maximal tumor size is 10 cm
• Previous liver resection or ablative therapy is permitted.

You may not qualify if:

• Patients with active hepatitis or encephalopathy related to liver failure
• Prior radiation therapy to the right upper abdomen, precluding reirradiation of the liver. That is, any previous radiation therapy in which a mean dose to the liver of 15 Gy in conventional fractionation was delivered, or previous doses to critical normal structures that would make re-irradiation unsafe. The PI should be called if there is any question of safety of re-irradiation.
• Eligible for RFA or alcohol ablation
• Eligible for TACE
• Prior uncontrolled, life threatening malignancy within the six months.
• Pregnancy is not permitted, and in women of child bearing age, a pregnancy test and acceptable methods of contraception are warranted.
• Previous gastric, duodenal or variceal bleed within the past 2 months.
• Commencement of coumadin use within the past 3 months.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Princess Margaret Hospital, Canada: collaborator

Study Sites (1)

University Health Network, Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

• Bujold A, Massey CA, Kim JJ, Brierley J, Cho C, Wong RK, Dinniwell RE, Kassam Z, Ringash J, Cummings B, Sykes J, Sherman M, Knox JJ, Dawson LA. Sequential phase I and II trials of stereotactic body radiotherapy for locally advanced hepatocellular carcinoma. J Clin Oncol. 2013 May 1;31(13):1631-9. doi: 10.1200/JCO.2012.44.1659. Epub 2013 Apr 1.

  PMID: 23547075 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiosurgery

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

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Laura Dawson, MD

  University Health Network, Princess Margaret Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2009
• First Posted: June 5, 2009
• Study Start: August 1, 2007
• Primary Completion: August 1, 2020
• Study Completion: December 8, 2020
• Last Updated: October 6, 2021

Record last verified: 2021-10

Locations

CA (1)