Clinical trial NCT02958163: Clinical Trial Comparing TACE With TACE + SABR in Stage BCLC B HCC (HepSTAR)
Official title: Randomized Controlled Phase II Trial Comparing Trans-Arterial Chemo-Embolization (TACE) With TACE Plus Stereotactic Ablative Radiotherapy (SABR) in Stage BCLC B Hepatocarcinoma (HepSTAR)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Liver Neoplasms
Hepatocellular Cancer
Keywords: Hepatocellular cancer
Stereotactic Body Radiotherapy
Chemoembolization, Therapeutic
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
Collaborators: name: Erasme University Hospital
name: Jules Bordet Institute
name: University of Liege
name: Clinique Saint Joseph, Liège
name: Centre Hospitalier Universitaire UCLouvain Namur
First posted: 2016-11-08
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This will be multicentre a phase II randomized controlled and open-label trial. It will compare the 6-months objective response (CR+PR) rates obtained with Drug Eluting Bead Trans-Arterial Chemo-Embolization (DEB-TACE) alone versus DEB-TACE followed by Stereotactic Ablative Radiotherapy (SABR) in patients with hepatocarcinoma stage BCLC B.

This trial will also include one substudy. This substudy will confront the immuno-histochemical results collected on tumoral biopsies to the biological and imaging (MRI) results. Every patient participating to the trial can also participate to this substudy.

Detailed description: The patients will be randomized in 2 arms determining the treatment they will receive:

Arm A: actual standard treatment = TACE Arm B: experimental arm = TACE + SABR

Eligibility criteria: Inclusion Criteria:

* Hepatocellular carcinoma larger than 3 cm and non-resectable, with a diagnosis established either by:

  * dynamic imaging (non-invasively), showing a typical contrast enhancement and wash-out
  * histopathology
* satellite lesions are allowed (at most three lesions) as long as the doses constraints are still achievable
* Hepatocellular carcinoma belonging to Barcelona Clinic Liver Cancer Stage System class B
* Tumor must be measurable on a multi-phase MRI according to mRECIST criteria
* Non-tumoral liver volume ≥ 800 cc
* Child-Pugh (CP) A to B7 cirrhosis
* HCC Patients can be included if they require treatment prior to liver transplantation
* ECOG performance status 0-1
* AST/ALT \< 5 times ULN
* Initial platelets ≥ 50 000 x 10E9/l, neutrophils \> 1500 x 10E9/l, Hb \> 9 g/dl
* Serum creatinine \< 1.5 X normal, or calculated Creatinine clearance rate ≥ 60 mL/min
* As tumor biopsy can be performed after inclusion, pure hepatocellular carcinoma but also mixed hepatocellular carcinoma will be allowed in this trial. Cholangiocarcinoma cannot be included.
* Written informed consent form to be signed,
* Patient willing and able to comply to the follow-up schedule
* Patients in fertile age should use a contraceptive method during treatment and 4 months after.

Exclusion Criteria:

* Eligibility for resection or ablative treatments
* Extra hepatic spread of the disease
* Previous treatment of the same lesion with TACE
* Previous treatment with selective internal radiotherapy or radiotherapy to the upper abdomen
* Uncontrolled Ascites
* Uncontrolled Encephalopathy
* Any clinical sign of acute viral or non-viral hepatitis (new serological testing are not required)
* Known current pregnancy
* Uncontrolled active co-morbidity

Primary outcomes:
measure: Objective response rate at 6 months
timeFrame: 6 months after the completion of treatment
Secondary outcomes:
measure: Time to progression
timeFrame: 1 year after the treatment completion
measure: Time to untreatable progression
timeFrame: 1 year after the treatment completion
measure: 6-months overall survival
timeFrame: 1 year after the treatment completion
measure: 1-year overall survival
timeFrame: 1 year after the treatment completion
measure: Acute toxicities
timeFrame: 6 months after treatment completion
measure: Late toxicities
timeFrame: 6 months after treatment completion
measure: Quality of life assessment by questionnaire at baseline
timeFrame: baseline
measure: Quality of life assessment by questionnaire at 2 months
timeFrame: 2 months
measure: Quality of life assessment by questionnaire at 6 months
timeFrame: 6 months after treatment completion
measure: Assessment by questionnaires of specific for hepatocarcinoma quality of life at baseline
timeFrame: baseline
measure: Assessment by questionnaires of specific for hepatocarcinoma quality of life at 2 months
timeFrame: 2 months after treatment completion
measure: Assessment by questionnaires of specific for hepatocarcinoma quality of life at 6 months
timeFrame: 6 months after treatment completion
measure: Overall response rate based on the MRI evaluation in Child Pugh B7 patients
timeFrame: 6 months
Other outcomes:
measure: Immuno-histochemical detection of tumoral markers on biopsy (AFP/CK19/DCP)
timeFrame: at time of biopsy
measure: Baseline biological detection of tumoral marker(s) : AFP +/- DCP
timeFrame: at baseline
measure: Biological detection of tumoral marker(s) (AFP +/- DCP) at 2 months after treatment
timeFrame: 2 months after treatment completion
measure: Biological detection of tumoral marker(s) (AFP +/- DCP) at 4 months after treatment
timeFrame: 4 months after treatment completion
measure: Biological detection of tumoral marker(s) (AFP +/- DCP) at 6 months after treatment
timeFrame: 6 months after treatment completion
measure: MRI description of tumors at the hepatobiliary phase at baseline
timeFrame: at baseline
measure: MRI description of tumors at the hepatobiliary phase at 2 months after treatment
timeFrame: 2 months after treatment completion
measure: MRI description of tumors at the hepatobiliary phase at 6 months after treatment
timeFrame: 6 months after treatment completion
Locations:
city: Jolimont
country: Belgium
facility: Hôpital de JOLIMONT
state: Hainaut
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire/CHC Saint Joseph
state: Liège
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc
state: Woluwé Saint Lambert
city: Brussels
country: Belgium
facility: Institut Jules Bordet/Hôpital Erasme
city: Namur
country: Belgium
facility: Clinique et Maternité Sainte Elisabeth/CHU Mont Godinne
Study officials:
affiliation: Cliniques Universitaires Saint Luc/MIRO
name: Xavier GEETS
role: PRINCIPAL_INVESTIGATOR
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Ivan BORBATH
role: PRINCIPAL_INVESTIGATOR
References: