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

Titre officiel

A Randomized Multi-Centre Phase III Study of Individualized Stereotactic Body Radiation Therapy (SBRT) Versus Trans-Arterial Chemoembolization (TACE) as a Bridge to Transplant in Hepatocellular Carcinoma.

Sommaire:

Cette étude vise à comparer la radiothérapie stéréotaxique corporelle (RTSC) à la chimioembolisation transartérielle (CETA) en tant que stratégie de transition chez les patients atteints d’un CHC qui subissent une greffe de foie. Nous proposons que la RTSC soit associée à des intervalles plus longs entre le traitement initial et la nécessité d’une reprise du traitement, par rapport à la CETA, en tant que « transition » vers une greffe du foie chez des sujets atteints d’un CHC.

Description de l'essai

Primary Outcome:

• To compare the duration of disease control in treated lesions when utilizing SBRT versus TACE as a bridging strategy for patients with HCC eligible for liver transplantation

Secondary Outcome:

• To compare participants with treatment-related adverse events as assessed by CTCAE v5.0
• Number of further interventions
• Rate of pathological response of treated lesion(s)
• Rate of radiological response of treated lesion(s)
• To assess Quality of Life by Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) Questionnaire
• To assess over survival
• To assess 90 day Post-transplant morbidity
• To assess 90 day Post-transplant mortality

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 tumour recurrence after transplantation. For patients undergoing local regional therapy as a bridge to transplantation, trans-arterial chemoembolization (TACE) is the most commonly utilized treatment. However, the best modality for patients undergoing treatment as a bridge to transplantation is unclear. A newer strategy for the treatment of HCC is stereotactic body radiation therapy (SBRT). This study will compare SBRT to TACE as a bridging strategy for patients with HCC undergoing liver transplantation.

Voir cet essai sur ClinicalTrials.gov