SIR-Spheres® Microspheres Versus Transarterial Chemoembolisation in Patients With Unresectable Hepatocellular Carcinoma

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00867750
• Date of registration: 13/03/2009
• Prospective Registration: No
• Primary sponsor: Sirtex Medical
• Public title: SIR-Spheres® Microspheres Versus Transarterial Chemoembolisation in Patients With Unresectable Hepatocellular Carcinoma SIRTACE
• Scientific title: Radioembolisation (RE) With SIR-Spheres® Microspheres Versus Transarterial Chemoembolisation (TACE) in Patients With Unresectable Hepatocellular Carcinoma (HCC). A Comparative, Prospective, Randomised, Open, Pilot Study.
• Date of first enrolment: March 2006
• Target sample size: 28
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00867750
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Germany, Spain

Contacts

• Name: Dr. Frank Kolligs, PD
• Affiliation: Universitäts-Klinikum München-Grosshadern

• Name: Dr Bruno Sangro, MD, PhD
• Affiliation: Clinica Universitaria de Navarra

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female patients, aged = 18 years

- Unequivocal diagnosis of primary HCC (confirmed by biopsy/histology or EASL criteria)

- Tumour characteristics as follows:

- Not more than 5 lesions

- If single, maximal diameter = 10 cm

- If multiple, sum of maximal diameters = 15 cm

- Lesions satellite to primary tumour of less than 1 cm in maximal diameter are
not included

- At least one quantifiable lesion on hepatic MRI

- Preserved liver function, corresponding to Child-Pugh class = B-7

- ECOG performance status = 2

- Life expectancy = 12 weeks

- Female patients of childbearing potential must have a negative pregnancy test prior
to inclusion in the trial and male and female patients must agree to use an effective
contraceptive method for the duration of the trial.

- Willing and able to provide written informed consent

Exclusion Criteria:

- Patients expected to undergo surgery (resection or transplantation) within the
24-week period after randomisation.

- Ascites, which is detectable on physical examination or clinically symptomatic (but
patients having ascites discovered by imaging only should not be excluded).

- Serum transaminases > 5 x ULN

- Lung shunt > 20%

- Extrahepatic disease

- Moderate to severe portal hypertension, as evidenced by any of the following criteria
(occurring in spite of using common criteria for prophylactic treatment and therapy):

- History of variceal haemorrhage in past 2 years

- History of hepatic encephalopathy

- Platelets < 50.000 /ml

- WBC < 3.000 / ml

- Previous TIPSS procedure

- Portal vein occlusion or hepatofugal flow.

- Impaired liver function

- Total serum bilirubin > 2.0 mg / dL

- Serum albumin < 3.0 g /dl

- creatinine > 2 mg / dL

- Chemotherapy or other experimental therapy within preceding 4 weeks

- Previous TAE / TACE

- Previous radiation therapy to liver or lungs

- Contraindications for angiography (severe peripheral vascular disease or
uncorrectable bleeding diathesis)

- Anatomical variants apparent on 99mTc-MAA scan precluding safe administration of RE

- Any decompensated concomitant disease

- Female patients who are pregnant, breast-feeding, or pre-menopausal and not
practising efficient contraceptive method (hormonal contraceptive, intra-uterine
device)



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Hepatocellular Carcinoma

Intervention(s)

Drug: Transarterial Chemoembolisation

Device: Radioembolisation (SIR-Spheres® microspheres)

Primary Outcome(s)

Health-related quality of life (HRQL) [Time Frame: 9 months]

Secondary Outcome(s)

Morphological tumour response; assessed using RESIST criteria [Time Frame: From the date of first treatment until disease progression]

Incidence rate of extra-hepatic disease [Time Frame: From the date of first treatment until disease progression]

Survival at 6 and 12 months [Time Frame: 6 and 12 months from the date of first treatment]

Incidence rate of portal vein invasion [Time Frame: From the date of first treatment until disease progression]

Overall survival [Time Frame: From the date of first treatment until death]

Functional tumour response; assessed via tumour marker reduction [Time Frame: From the date of first treatment until disease progression]

Progression Free Survival (PFS); calculated from the date of first treatment [Time Frame: From the date of first treatment until disease progression]

Pharmaco-economic assessment [Time Frame: 9 months]

Secondary ID(s)

SX-PHCC-001

STX0306

Source(s) of Monetary Support

Please refer to primary and secondary sponsors