Know Cancer

or
forgot password

Radioembolisation (RE) With SIR-Spheres® Microspheres Versus Transarterial Chemoembolisation (TACE) in Patients With Unresectable Hepatocellular Carcinoma (HCC). A Comparative, Prospective, Randomised, Open, Pilot Study.


Phase 2
18 Years
N/A
Not Enrolling
Both
Hepatocellular Carcinoma

Thank you

Trial Information

Radioembolisation (RE) With SIR-Spheres® Microspheres Versus Transarterial Chemoembolisation (TACE) in Patients With Unresectable Hepatocellular Carcinoma (HCC). A Comparative, Prospective, Randomised, Open, Pilot Study.


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Health-related quality of life (HRQL)

Outcome Time Frame:

9 months

Safety Issue:

No

Principal Investigator

Dr Bruno Sangro, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Clinica Universitaria de Navarra

Authority:

European Union: European Medicines Agency

Study ID:

SX-PHCC-001

NCT ID:

NCT00867750

Start Date:

March 2006

Completion Date:

June 2011

Related Keywords:

  • Hepatocellular Carcinoma
  • HCC
  • RE
  • Yttrium-90
  • SIR-Spheres microspheres
  • TACE
  • Radioembolisation
  • Transarterial Chemoembolisation
  • Carcinoma
  • Carcinoma, Hepatocellular

Name

Location