Clinical Trial Comparing TACE With TACE + SABR in Stage BCLC B HCC (HepSTAR)
NCT ID: NCT02958163
Last Updated: 2017-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
3 participants
INTERVENTIONAL
2017-02-20
2017-10-17
Brief Summary
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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
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Arm A: actual standard treatment = TACE Arm B: experimental arm = TACE + SABR
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Trans-Arterial Chemo-embolization (TACE)
Trans-arterial Embolisation will be performed with drug-eluting beads loaded with Doxorubicin. First session will be given within 4 weeks after randomization.
4-phase MRI will be performed every 2 months to assess the response. In case of insufficient response according to the MRI performed at 2 or 4 months, a second or third session of DEB-TACE will be allowed, according to the physician's choice.
Once complete response is achieved, the follow-up period will start. The date of the last session of TACE corresponds to the treatment completion date.
Trans-arterial Chemo-Embolization
Trans-Arterial Chemo-Embolization will be performed with Doxorubicin-Eluting-Beads (DEB-TACE). It will be performed in each arm of treatment.
Doxorubicin
Drug-eluting Bead for Trans Arterial Chemo-Embolization will be loaded with Doxorubicin.
TACE+Stereotactic Ablative Radiotherapy
The first part of the treatment, which is the DEB-TACE delivery, will be exactly the same than in arm A. The radiotherapy (SABR) will then start within 4 to 6 weeks after.
Afterwards, 4-phase MRI will be performed every 2 months to assess the response. In case of insufficient response according to the MRI performed at 2 or 4 months, a second or third session of DEB-TACE will be allowed, according to the physician's choice.
Once complete response is achieved, the follow-up period will start. The date of the last SABR fraction or the last session of TACE corresponds to the treatment completion date.
Trans-arterial Chemo-Embolization
Trans-Arterial Chemo-Embolization will be performed with Doxorubicin-Eluting-Beads (DEB-TACE). It will be performed in each arm of treatment.
Doxorubicin
Drug-eluting Bead for Trans Arterial Chemo-Embolization will be loaded with Doxorubicin.
Stereotactic Ablative Radiotherapy
SABR schemes will be adapted according to the CP score and the vicinity of surrounding organs at risk. These are the different schemes proposed in this trial:
48Gy = 3x16Gy BED 124.8Gy ( α/β=10) 50Gy = 5x10Gy BED 100Gy ( α/β=10) 48Gy = 6x8Gy BED 86.4Gy ( α/β=10) 40Gy = 5x8Gy BED 72Gy ( α/β=10)
For patients with Child-Pugh (CP) A cirrhosis : the choice of the scheme will be left to each physician. The highest BED should be favored if dose constraints to the organs at risk are respected.
For patients with CP B cirrhosis : only the latter scheme will be allowed: 40Gy = 5x8Gy.
Interventions
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Trans-arterial Chemo-Embolization
Trans-Arterial Chemo-Embolization will be performed with Doxorubicin-Eluting-Beads (DEB-TACE). It will be performed in each arm of treatment.
Doxorubicin
Drug-eluting Bead for Trans Arterial Chemo-Embolization will be loaded with Doxorubicin.
Stereotactic Ablative Radiotherapy
SABR schemes will be adapted according to the CP score and the vicinity of surrounding organs at risk. These are the different schemes proposed in this trial:
48Gy = 3x16Gy BED 124.8Gy ( α/β=10) 50Gy = 5x10Gy BED 100Gy ( α/β=10) 48Gy = 6x8Gy BED 86.4Gy ( α/β=10) 40Gy = 5x8Gy BED 72Gy ( α/β=10)
For patients with Child-Pugh (CP) A cirrhosis : the choice of the scheme will be left to each physician. The highest BED should be favored if dose constraints to the organs at risk are respected.
For patients with CP B cirrhosis : only the latter scheme will be allowed: 40Gy = 5x8Gy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Erasme University Hospital
OTHER
Jules Bordet Institute
OTHER
University of Liege
OTHER
Clinique Saint Joseph, Liège
OTHER
Centre Hospitalier Universitaire UCLouvain Namur
OTHER
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
OTHER
Responsible Party
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Principal Investigators
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Xavier GEETS
Role: PRINCIPAL_INVESTIGATOR
Cliniques Universitaires Saint Luc/MIRO
Ivan BORBATH
Role: PRINCIPAL_INVESTIGATOR
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Locations
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Hôpital de JOLIMONT
Jolimont, Hainaut, Belgium
Centre Hospitalier Universitaire/CHC Saint Joseph
Liège, Liège, Belgium
Cliniques Universitaires Saint Luc
Brussels, Woluwé Saint Lambert, Belgium
Institut Jules Bordet/Hôpital Erasme
Brussels, , Belgium
Clinique et Maternité Sainte Elisabeth/CHU Mont Godinne
Namur, , Belgium
Countries
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Other Identifiers
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28248368
Identifier Type: -
Identifier Source: org_study_id