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SBRT as Bridging Therapy for Hepatocellular Carcinoma Patients on Transplant Waitlist

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ClinicalTrials.gov Identifier: NCT03950102
Recruitment Status : Unknown
Verified May 2019 by Dr. Tiffany Cho-Lam Wong, The University of Hong Kong.
Recruitment status was:  Recruiting
First Posted : May 15, 2019
Last Update Posted : May 28, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Tiffany Cho-Lam Wong, The University of Hong Kong

Study Description
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Brief Summary:
This is a single center, prospective study to assess the efficacy and safety of using stereotactic body radiation therapy (SBRT) as bridging treatment for hepatocellular carcinoma (HCC) patients on transplant waitlist.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Radiation: SBRT Not Applicable

Detailed Description:

The study population includes patients 18 years of age or older with HCC, who are accepted on waiting list for deceased donor liver transplantation (DDLT).

Patient will be assessed in a multidisciplinary committee and they will receive SBRT unless otherwise contraindicated. Patients will undergo SBRT under standard protocol.

Patients with HCC beyond University of California, San Francisco criteria (UCSF) will be removed from waitlist.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Study of Stereotactic Body Radiation Therapy as a Bridging Therapy for Hepatocellular Carcinoma Patients on Waiting List for Liver Transplantation
Actual Study Start Date : July 1, 2015
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 31, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: SBRT
SBRT will be used as the primary bridging therapy for HCC patients on waitlist
 Radiation: SBRT
Radiation dose of 27.5-50Gy in 5 fractions over 5-14 days with a radical dose as high as achievable based on mean liver dose (MLD), while fulfilling the dose constraints of OARs


Outcome Measures
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Primary Outcome Measures :
  1. Risk of classical radiation induced liver disease (RILD) after SBRT [ Time Frame: From time of SBRT to 3 months afterwards ]
    Defined as elevated liver transaminases >5 times of upper normal limit or worsening of Child's score by >2 within 3 months after SBRT

  2. Rate of transplant complication [ Time Frame: From time of transplant to 1 months afterwards ]
    Perioperative complication will be assessed according to Clavien-Dindo classification


Secondary Outcome Measures :
  1. Rate of dropout from transplant waitlist [ Time Frame: From time of enrolment to up to 2 years ]
    All HCC patients on waitlist will be assessed regularly and will be removed from waitlist if HCC stage is beyond UCSF criteria.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Radiological diagnosis of HCC confirmed according to AASLD criteria
  2. All patients who are accepted on deceased donor waiting list
  3. HCC within UCSF criteria (defined as solitary tumor <=6.5cm OR up to 3 tumors <=4.5cm, total sum <=8cm)

Exclusion Criteria:

  1. age <18 year old;
  2. Child's C cirrhosis;
  3. Eastern Cooperative Oncology Group (ECOG) score >2;
  4. presence of extrahepatic metastasis;
  5. radiological tumor invasion to portal, hepatic vein or its branches;
  6. absolute contraindications to RT (e.g. previous RT to liver);
  7. positive pregnancy test;
  8. unwilling or unable to adhere to study requirements and procedure;
  9. any other condition, in the investigator's judgment, that increases the risk of SBRT or prevents safe trial participation.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03950102


Contacts
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Contact: Tiffany Wong, MBChB 22554848 wongtcl@hku.hk

Locations
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Hong Kong
Queen Mary Hospital Recruiting
Hong Kong, Hong Kong
Contact: Tiffany Wong, MBChB    22554848    wongtcl@hku.hk   
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Tiffany Wong, MBChB The University of Hong Kong
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. Tiffany Cho-Lam Wong, Clinical Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03950102    
Other Study ID Numbers: UW15-191
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: May 28, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases