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

About this trial

Last updated 7 years ago

Study ID

DOSISPHERES-01

Status

Completed

Type

Interventional

Phase

Phase 2

Placebo

Accepting

All Ages

All Sexes

Trial Timing

Ended 7 years ago

What is this trial about?

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.

What are the participation requirements?

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