MedDataX Logo

SBRT for Hepatocellular Carcinoma Patients With Partial Response to TACE

NCT ID: NCT02221778

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Carcinoma, Hepatocellular

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Carcinoma, Hepatocellular SBRT

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SBRT

SBRT according to the intervention description

Group Type EXPERIMENTAL

SBRT

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Andre Tsin Chih Chen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Flair J Carrilho, MD, PhD

Role: STUDY_CHAIR

University of Sao Paulo

Andre T Chen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

São Paulo, , Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 34211773 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RT-02/2014

Identifier Type: -

Identifier Source: org_study_id