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Internal Radiation Therapy for Hepatocellular Carcinomas With Therasphere: Optimized Dosimetry Versus Standard Dosimetry

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ClinicalTrials.gov Identifier: NCT02582034
Recruitment Status : Completed
First Posted : October 21, 2015
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Center Eugene Marquis

Brief Summary:
The purpose of this study is to determine whether a treatment with Therasphere which is optimized is more efficient compared to a standard treatment for patients suffering from hepatocellular carcinomas.

Condition or disease Intervention/treatment Phase
Adenoma, Liver Cell Radiation: Optimized Internal Radiation Therapy Radiation: Standard Internal Radiation Therapy Phase 2

Detailed Description:
For patients suffering from hepatocellular carcinoma, a palliative treatment can be proposed if tumor expansion is limited to the liver. One of palliative treatment is the the Selective Internal Radiation Therapy (SIRT) with Therasphere®. This treatment is made secure by performing a diagnostic angiogram coupled with a hepatic perfusion scintigraph with which patients at risk of complications are identified and excluded. The treatment objective, with the standard dosimetric approach, is to deliver an absorbed dose of 120 ± 20 Gy to the treated hepatic volume, most often one lobe. Recent retrospective trials show that an optimized dosimetric approach, considering the dose absorbed by the tumor, is technically achievable and would probably make it possible to obtain a better effectiveness. In our experience, treatment personalisation have been described to be used for 60% of the patients with a tumor larger than 7 cm underlying the clinical impact of this new approach.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Selective Internal Radiation Therapy for Hepatocellular Carcinomas With Yttrium-90 Loaded Microspheres: Optimized Dosimetry Versus Standard Dosimetry
Actual Study Start Date : December 2015
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Arm Intervention/treatment
Active Comparator: Standard dosimetry
Standard Internal Radiation Therapy : Dose of radiation delivered to the tumoral volume is fixed : 120 Gray (GY)
Radiation: Standard Internal Radiation Therapy

Injection of yttrium-90 microspheres (TheraSphere®) is performed during the therapeutic angiogram, directly into the hepatic artery (left or right, or even segmental).Standard dosimetry arm: the activity to be administered is calculated so as predictive dosimetry:

  • An absorbed dose of 120 ± 20 Gy to the treated volume (whatever the tumor absorbed dose)
  • A pulmonary dose < 30 Gy for one treatment and < 50 Gy in cumulative dose in case of multiple treatments.

Experimental: Optimized dosimetry
Optimized Internal Radiation Therapy : Dose of radiation absorbed by the tumor is > 205 GY, if possible 250 or 300 Gy.
Radiation: Optimized Internal Radiation Therapy

Injection of yttrium-90 microspheres (TheraSphere®) is performed during the therapeutic angiogram, directly into the hepatic artery (left or right, or even segmental).

Optimized dosimetry arm: the activity to be administered is calculated so as to deliver predictive dosimetry:

  • An absorbed dose to the tumor of at least ≥ 205 Gy and if possible exceeding 250 Gy or even 300 Gy
  • A dose at the treated healthy liver < 120 Gy in case of lobar treatment
  • Dose to the treated healthy liver can exceed 120 Gy in case of segmental treatment and hepatic reserve > 30%
  • A pulmonary dose < 30 Gy for one treatment and < 50 Gy in cumulative dose in case of multiple treatments.




Primary Outcome Measures :
  1. The primary endpoint is to compare the response rate of the treated lesion at the first radioembolization, evaluated using European Association for the Study of the Liver (EASL) criteria of yttrium-90 marked glass microspheres SIRT [ Time Frame: 3 months after treatment administration ]

Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: Up to 12 months ]
  2. Overall survival [ Time Frame: Up to 30 months after inclusion of the 1st patient ]
  3. Related Adverse Events in both arms as assessed by National Cancer Institute criteria (National Cancer Institute Common Terminology Criteria for Adverse Events, (NCI CTCAE) version 4). [ Time Frame: Up to 12 months ]
  4. Progression free survival not accessible to SIRT [ Time Frame: Up to 12 months after treatment administration ]
  5. Post-therapeutic dosimetry measured by Positron emission tomography-computed tomography PET / CT [ Time Frame: Day one of treatment administration ]
    Dose delivered to the treated liver, the tumors, healthy liver and lings



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18,
  • Written free and informed consent,
  • Histologically demonstrated Hepatocellular Carcinoma (HCC), not a candidate for surgery or local ablative treatment (radio frequency, etc.)
  • Barcelona Clinic Liver Cancer (BCLC) classification A, B or C,
  • At least one lesion ≥ 7 cm,
  • Hepatic reserve (hepatic parenchyma not treated) after the first SIRT ≥ 30%,
  • Unilateral involvement, minimal bilateral involvement allowed only with a hepatic reserve ≥ 30% after SIRT
  • Child A classification only, or B but with bilirubinemia <35 micromol/L,
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1,
  • Patients whose biological parameters meet the following criteria:

    • Hemoglobin ≥ 8.5 g/dL,
    • Granulocytes ≥ 1500/mm3,
    • Platelets ≥ 50,000/mm3,
    • Bilirubinemia <35 micromol per liter,
    • Transaminases ≤ five times the upper limit of normal,
    • Creatininemia ≤ 1.5 times the normal upper limit,
  • Expected survival over 12 weeks,
  • Negative pregnancy test for women of childbearing age,
  • If sorafenib has been taken the diagnostic angiogram must follow it by at least four weeks after its stop.

Exclusion Criteria:

  • HCC operable or accessible to a local ablative treatment (radio frequency),
  • Hepatectomy history unless a segmental treatment is considered, with a hepatic reserve ≥ 30% after SIRT,
  • Prior treatment with sorafenib unless stopped at least four weeks earlier,
  • History of chemo-embolization of the principal lesion, except in case of nodular residual lesion measuring at least 7 cm or in case of progression after initial response,
  • Bilateral disease requiring a whole liver injection or with a hepatic reserve < 30% after SIRT
  • Treatment of another cancer less than one year earlier,
  • Extra-hepatic metastases other than adenopathies of the hilum smaller than 2 cm,
  • >70% tumor invasion of the liver,
  • Bilirubinemia ≥ 35 µmol/L,
  • A Severe underlying biliary pathology:
  • Bile duct anomaly (stent, dilation) Cirrhosis of biliary origin,
  • Women of childbearing age without contraception
  • Pregnant or nursing women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02582034


Locations
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France
CHU Henri Mondor
Créteil, France, 94000
CHU Saint Eloi
Montpellier, France, 34925
Centre Eugène Marquis
Rennes, France, 35042
Gustave Roussy
Villejuif, France
Sponsors and Collaborators
Center Eugene Marquis
Investigators
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Study Chair: Etienne GARIN, Pr Centre Eugène Marquis
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Center Eugene Marquis
ClinicalTrials.gov Identifier: NCT02582034    
Other Study ID Numbers: DOSISPHERES-01
First Posted: October 21, 2015    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Keywords provided by Center Eugene Marquis:
Optimized Dosimetry versus standard Dosimetry
Internal Radiation Therapy
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Adenoma
Adenoma, Liver Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases