Trial document




drksid header

  DRKS00008566

Trial Description

start of 1:1-Block title

Title

HEpatocellular carcinoma stereotactic RAdiotherapy CLinical Evaluation Study

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

HERACLES

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

[---]*

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

HCC is a disease with rising incidence and mortality worldwide mostly due to the rise of HCV and non-alcoholic steatohepatitis (NASH). The overall five-year survival rate is only 5% with more than 70% of the patients presenting with advanced disease precluding curative treatment such as transplantation, resection, or tumours <3 cm suitable for ablation. About 70% of the patients with HCC have no metastatic disease at initial diagnosis but at the same time there are no curative options due to the following reasons: tumour size, number of lesions and/or location. For patients who are not eligible for resection or liver transplantation, treatment options include local nonsurgical methods of tumour ablation (radiofrequency ablation [RFA], percutaneous ethanol injection [PEI]), transarterial chemoembolization (TACE), radiation therapy, and systemic therapy. In about 15-20% of the patients who would benefit from local therapy, none of the classical local methods can be offered due to the respective limitations and contraindications of these methods. Stereotactic body radiotherapy (SBRT) has the potential to fill this gap. SBRT is high precision image guided radiotherapy (IGRT) with few sessions of high dose focussed radiotherapy. In this study SBRT will be offered as per routine for patients with HCC where radiotherapy is indicated. There is good evidence that the effects of SBRT for patients with HCC produces are achieved whilst maintaining an excellent quality of life (Klein J. et al. IJROBP in press; Méndez Romero A et al. IJROBP 2008). In the future SBRT for HCC will be tested with molecular targeted agents and c-Met inhibition is one strategy that we aim to study. The proposed pilot study aims to prepare a subsequent multicentre trial testing this combination clinically.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00008566
  •   2016/03/10
  •   [---]*
  •   yes
  •   Approved
  •   374/15, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   C22.0 -  Malignant neoplasm: Liver cell carcinoma
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Diagnosis of hepatocellular carcinoma, indication: Stereotactic Body Radiotherapy. Treatment with SBRT. Keeping record of recruitment, toxicity and outcome parameters.
  •   Diagnosis of hepatocellular carcinoma, indication: Transarterial Chemoembolization. Treatment with TACE (Trans-Arterial Chemo-Embolization). Keeping record of recruitment, toxicity and outcome parameters.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   No
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Feasibility, i.e. recruitment and conduct of a prospective study using SBRT or TACE according to their standard medical indications

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Toxicity acute and late measured as NCI-CTCAE v4.0, progression free survival (PFS), overall survival (OS)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2016/07/19
  •   75
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Histologically or cytologically confirmed hepatocellular carcinoma OR diagnosis made with characteristic enhancement in 4-Phase CT or MRI corresponding to AASLD- / EASL guidelines in cirrhotic patients; Discussion in a routine multidisciplinary tumour board; Understanding of procedure, significance and consequences of the study; given informed consent. SBRT Group: Patients unsuitable for surgery, TACE*, RFA, or alcohol ablation / *TACE patients will be recruited for control group; bilirubin has to be < 4 x the upper limit of normal, AST or ALT < 6 x the upper limit of normal, international normalized ratio < 1.5 except if patients are on oral anticoagulation, haemoglobin≥ 90 g/L, platelets ≥ 50 x 10^9/L, and neutrophils ≥ 1.0 x 10^9/L. TACE Group: Patients suitable for TACE; bilirubin has to be <2 mg/dL, AST or ALT < 6 x the upper limit of normal, international normalized ratio < 1.5 except if patients are on oral anticoagulation, haemoglobin≥ 90 g/L, platelets ≥ 50 x 10^9/L, and neutrophils ≥ 1.0 x 10^9/L

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Child-Turcotte-Pugh (CTP) C liver score; Hepatic encephalopathy more than Grade 1 according to Child Pugh criteria; Active hepatitis; Gastric, duodenal or variceal bleed within 2 months of registration; Prior radiotherapy of the region to be treated; For female patients: Pregnancy, planned pregnancy

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
    • Ms.  Prof. Dr. med.  Anca Ligia  Grosu 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
    • Mr.  Prof. Dr. med.  Thomas B.  Brunner 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
    • Mr.  Dr. med.  Simon  Kirste 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • DKTK Deutsches Konsortium für Translationale Krebsforschung / Site Coordinator Freiburg, c/o Tumorzentrum CCCF
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.