SBRT for Hepatocellular Carcinoma Patients With Partial Response to TACE

NCT02221778 | Active Not Recruiting Phase 2

• 1 other identifier: RT-02/2014
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Carcinoma, Hepatocellular; SBRT

Outcome Measures

Primary Outcomes (1)

• Local Progression Free Survival

  Local Progression Free Survival will be measured on triphasic Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) when clinically indicated. The exam will be performed every 3 months after the end of treatment. The tumor response will be measured according to the modified RECIST (mRECIST) directed to the HCC study. Local Progression Free Survival will be defined as increase of 20% in the sum of all diameters of the treated lesions. Time-to-event will be counted from the initiation of SBRT

  5 years

Secondary Outcomes (3)

• Distant Progression Free Survival

  5 years

• Toxicity

  5 years

• Overall Survival

  5 years

Study Arms (1)

SBRT

EXPERIMENTAL

SBRT according to the intervention description

Radiation: SBRT

Interventions

SBRT RADIATION

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

SBRT

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• HCC diagnosis according to the American Association for the Study of Liver Diseases (AASLD) 2010 criteria
• Tumor Stage
• liver only disease
• tumor thrombus at segment is allowed
• no extra hepatic metastases
• tumor encompassing less than 50% of hepatic volume
• previous treatment with Transarterial Chemo Embolization (TACE) - patient must have performed at least 2 sessions of TACE and have signs of viable tumor in CT or MRI performed 30-40 days after last TACE
• presence of measurable lesion (at least one lesion that can be measured equal or more than 1 cm in CT or MRI).
• Maximum lesion size of 10 cm.
• Liver residual volume equal or more than 700cc or 40% of total liver volume
• Child-Pugh A or absence of hepatic cirrhosis
• absence of encephalopathy or ascitis on clinical exam
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Lab exams:
• hemoglobin \> or equal 8 mg/dl

You may not qualify if:

• Patients with more than 5 discrete lesions in the liver
• Main or common biliary duct invasion
• Patients with main portal vein tumor thrombus or more than 2 portal branch thrombus
• Patients in systemic treatment (sorafenib, chemotherapy). There should be an interval of at least 4 weeks between any medication for treatment of HCC and the current study treatment
• Previous radiation to upper abdomen
• Patients with other malignant neoplasms or previous malignant neoplasms will be accepted in the study if HCC prognosis is worse
• Patients with ischemic myocardial infarction within the last 6 months
• Patients with large esophageal varices with red color sign or bleeding within the last 3 months
• Patients with symptoms of colitis, enteritis, esophagitis, fistula, ileus, necrosis, stenosis or ulcer
• Patients with severe anorexy, constipation, dehydration, diarrhea or vomiting
• Patients unable to understand and sign written informed consent

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Instituto do Cancer do Estado de Sao Paulo, Hospital das Clinicas da Faculdade de Medicina da USP

São Paulo, 01246000, Brazil

Location

Related Publications (1)

• Chen ATC, Payao F, Chagas AL, De Souza Melo Alencar RS, Tani CM, da Conceicao Vasconcelos KGM, de Souza Rocha M, de Andrade Carvalho H, Hoff PMG, Carrilho FJ. Feasibility of SBRT for hepatocellular carcinoma in Brazil - a prospective pilot study. Rep Pract Oncol Radiother. 2021 Apr 14;26(2):226-236. doi: 10.5603/RPOR.a2021.0035. eCollection 2021.

  PMID: 34211773 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

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

Study Officials

• Flair J Carrilho, MD, PhD

  University of Sao Paulo

  STUDY CHAIR

• Andre T Chen, MD, PhD

  University of Sao Paulo

  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: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 19, 2014
• First Posted: August 20, 2014
• Study Start: August 1, 2014
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

BR (1)