Stereotactic Body Radiation Therapy (SBRT) Versus Trans-Arterial Chemoembolization (TACE) as Bridge to Liver Transplant

Phase 2

Completed

• Conditions: Hepatocellular Carcinoma; HCC
• Interventions: Radiation: Stereotactic Body Radiation Therapy (SBRT); Procedure: Trans-Arterial Chemoembolization (TACE); Drug: Doxorubin

• Registration Number: NCT02182687
• Lead Sponsor: Lahey Clinic

Brief Summary

This study will compare stereotactic body radiation therapy (SBRT) to trans-arterial chemoembolization (TACE) as a bridging strategy for patients with HCC undergoing orthotopic liver transplantation. We propose that SBRT will be associated with longer time intervals between initial treatment and the need for retreatment, compared to TACE, as a "bridge" to orthotopic liver transplantation.

Detailed Description

For patients with hepatocellular carcinoma (HCC) who are waiting for a liver transplant, local treatment of their disease has become the standard of care in an effort to decrease dropout rates and as a means of reducing tumor recurrence after transplantation. However, the best modality for patients undergoing treatment as a bridge to transplantation is unclear. This study will compare stereotactic body radiation therapy (SBRT) to trans-arterial chemoembolization (TACE) as a bridging strategy for patients with HCC undergoing orthotopic liver transplantation. We propose that SBRT will be associated with longer time intervals between initial treatment and the need for retreatment, compared to TACE, as a "bridge" to orthotopic liver transplantation.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-23
• Study First Submitted QC: 2014-07-07
• Study First Posted: 2014-07-08
• Primary Completion: 2021-10
• Study Completion: 2021-10
• Results First Submitted: 2023-09-05
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-07
• Last Update Submitted: 2024-02-07
• Results First Posted: 2024-03-05
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Stereotactic Body Radiation Therapy (SBRT)	Stereotactic Body Radiation Therapy (SBRT)
Arm B	Trans-Arterial Chemoembolization (TACE)	Trans-Arterial Chemoembolization (TACE) Drug: Doxorubin
Arm B	Doxorubin	Trans-Arterial Chemoembolization (TACE) Drug: Doxorubin

Primary Outcome Measures

Name	Time	Method
Freedom From Progression Over Time	3, 6 and 12 Months	Time from SBRT and TACE intervention to progression was tracked for subject receiving protocol intervention. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesion.

Secondary Outcome Measures

Name	Time	Method
Toxicity To Compare Participants With Treatment-related Adverse Events as Assessed by CTCAE	At each treatment, 2 weeks post treatment, 2 months post treatment, 5 months post treatment, every 3 months until 24 months post treatment	Grade 3 or greater toxicity with treatment-related adverse events was tracked at protocol specific time points. Grading of events was according to CTCAE.
Number of Participants Who Require Further Interventions Prior to Liver Transplant	2 weeks post treatment, 2 months post treatment, 5 months post treatment, every 3 months until 24 months post treatment	Each patient on each arm was followed to see how if further treatment interventions were needed prior to liver transplant. This outcome summarizes the number of participants who needed further treatment.
Pathologic Response of Treated Lesion(s)	At time of liver transplant	Pathologic complete response was recorded for patients in both arms after completion of liver transplant. Explanted liver was reviewed by the pathologist to determine if residual tumor was identified.
Radiologic Response of Treat Lesion(s)	Baseline, 3 months post-treatment, 6 months post-treatment, every 3 months thereafter until 2 years post treatment	Number of patients with a radiographical response to treatment.The status of each treated tumor/target lesion was assessed by MRI or CT scan and classified as progression if there was tumor growth (excluding growth due to biloma or abscess formation), residual or new enhancement of the ablated tumor (excluding benign peri-ablational enhancement), or contiguous viable tumor as determined by mRECIST Criteria.
Quality of Life - Questionnaires Include PIQ-6 and SF-36v2 Health Survey	Baseline, 2 weeks post-treatment, 6 months post-treatment	Quality of life was assessed with Short Form 36 Health Survey (SF-36v2®) and Pain Impact Questionnaire (PIQ-6TM) Health Survey. Data was stored and scored with Pro CoRE 2.0 Smart Measurement® System. Scores were analyzed at three time points, baseline-before the first treatment, acute response-2 weeks post the first treatment, and long term response - 6 months after the first treatment.; The PIQ-6 Pain Impact Questionnaire measures how a subject's pain affects every day activities. The SF-36v2 Health Survey measures functional health and well-being from the subject's point of view. The survey's scores range from 0-100, with 0 having the most disability and a score of 100 being equivalent to no disability.

Trial Locations

Locations (1)

Lahey Hospital & Medical Center; 🇺🇸 Burlington, Massachusetts, United States