Clinical trial NCT02221778: SBRT for Hepatocellular Carcinoma Patients With Partial Response to TACE
Official title: Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma Patients With Partial Response to Transarterial Chemoembolization
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Carcinoma, Hepatocellular
Keywords: Carcinoma, Hepatocellular
SBRT
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2014-08-20
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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
* neutrophils \> or equal 1.200/mm³
* platelets \> or equal 45.000/mm³
* alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than 6 times the upper normal limit
* bilirubin equal or \< 2 mg/dl
* international normalized ratio (INR) \< 1.7
* serum creatinine equal or \< 1.5 times the upper normal limit or creatinine clearance \> or equal 60 ml/min
* Albumin \>2.8 mg/dl
* not being pregnant - a negative pregnancy test is required (for women). Patients in fertile age should use a contraceptive method during treatment and 4 months after.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Local Progression Free Survival
timeFrame: 5 years
Secondary outcomes:
measure: Distant Progression Free Survival
timeFrame: 5 years
measure: Toxicity
timeFrame: 5 years
measure: Overall Survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo, Hospital das Clinicas da Faculdade de Medicina da USP
Study officials:
affiliation: University of Sao Paulo
name: Flair J Carrilho, MD, PhD
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Andre T Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.