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SBRT for Hepatocellular Carcinoma Patients With Partial Response to TACE

NCT02221778 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-12-06

No results posted yet for this study

Summary

This is a pilot study where patients with Hepatocellular Carcinoma (HCC) that have failed Transarterial Chemoembolization (TACE) will be treated with Stereotactic Body Radiation Therapy (SBRT). The focus of the study will be to evaluate safety and efficacy in our population of patients.

Conditions

  • Carcinoma, Hepatocellular

Interventions

RADIATION

SBRT

SBRT will be prescribed according to the Radiation Therapy Oncology Group (RTOG) 1112 protocol using Mean Liver Dose (MLD) as parameter. MLD will be calculated using Liver minus Gross Tumor Volume (GTV). Prescription dose will follow the scheme below: Prescription dose(Gy) / (MLD) (Gy) 50 / 13 45 / 15 40 / 15 35 / 15.5 30 / 16 27.5 / 17 If the dose constraints cannot be met, prescription will be according to the level immediately bellow. Treatment will be delivered in 5 fractions in consecutive working days

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Flair J Carrilho, MD, PhD · University of Sao Paulo

  • Andre T Chen, MD, PhD · University of Sao Paulo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02221778 on ClinicalTrials.gov