A prospective, multicentre, randomised, controlled study evaluating SIR-Spheres® Y-90 resin microspheres preceding standard cisplatin-gemcitabine (CIS-GEM) chemotherapy versus CIS-GEM chemotherapy alone as first-line treatment of patients with unresectable intrahepatic CholangioCArcinoma.
- Conditions
- billiary tract cancerintrahepatic cholangiocarcinoma10019815
- Registration Number
- NL-OMON47572
- Lead Sponsor
- Sirtex Technology Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
a) Willing, able and mentally competent to provide written informed consent
b) Aged 18 years or older
c) Histologically or cytologically confirmed unresectable and/or non ablatable
intrahepatic cholangiocarcinoma
d) Liver-only or liver predominant intrahepatic cholangiocarcinoma. Patients
are permitted to have loco-regional lymph node involvement defined as: portal
LN * 2 cm and/or para aortic LN * 1.5 cm in longest diameter, and/or up to 2
indeterminate lung lesions < 1 cm if these lung lesions are PET negative.
e) Chemotherapy naïve. Adjuvant chemotherapy is not permitted
f) ECOG performance status 0 or 1,
g) Adequate haematological function defined as:
Haemoglobin * 10g/dL
WBC * 3.0 x 109/L
Absolute neutrophil count (ANC) * 1.5 x 109/L
Platelet count * 100,000/mm3,
h) Adequate liver function defined as:
Total bilirubin * 30 *mol/L (1.75 mg/dL)
Albumin * 30 g/L
i) Adequate renal function defined as:
Serum urea and serum creatinine < 1.5 times upper limit of normal (ULN)
Creatinine clearance * 45 ml/min (calculated with Cockcroft-Gault Equation)
All blood test results must be within 14 days prior to randomisation.
j) Life expectancy of at least 3 months without any active treatment
k) Female patients must either be postmenopausal, sterile (surgically or
radiation- or chemically-induced), or if sexually active use an acceptable
method of contraception during the study.
l) Male patients must be surgically sterile or if sexually active must use an
acceptable method of contraception during the study.
m) Considered suitable to receive either treatment regimen in the clinical
judgement of the treating investigator.
a) Patients with only non-measurable lesions in the liver according to RECIST
criteria
b) Incomplete recovery from previous liver surgery, e.g. unresolved biliary
tree obstruction or biliary sepsis or inadequate liver function
c) Biliary stenting in situ
d) Main trunk Portal Vein Thrombosis (PVT)
e) Ascites, even if controlled with diuretics. (A minor peri-hepatic rim of
ascites detected at imaging is acceptable.)
f) Mixed HCC-ICC disease.
g) History of prior malignancy. Exceptions include in-situ carcinoma of the
cervix treated by cone-biopsy/resection, non-metastatic basal and/or squamous
cell carcinomas of the skin, recurrent intra-hepatic cholangiocarcinoma post
local treatment, or any early stage (stage I) malignancy adequately resected
with curative intent at least 5 years prior to study entry
h) Suspicion of any bone metastasis/metastases or central nervous system
metastasis/metastases on clinical or imaging examination.
i) Prior internal or external radiation delivered to the liver.
j) Pregnancy; breast feeding,
k) Participation within 28 days prior to randomisation, in an active part of
another clinical study that would compromise any of the endpoints of this study.
l) Evidence of ongoing active infection that may affect treatment feasibility
or outcome
m) Prior Whipple*s procedure
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint:<br /><br>Survival at 18 months</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints:<br /><br>- Liver-specific PFS<br /><br>- PFS at any site<br /><br>- Objective response rate by RECIST 1.1 and refined RECIST* - liver<br /><br>- Objective response rate by RECIST 1.1 and refined RECIST* - at any site<br /><br>- Overall Survival<br /><br>- Liver surgical resection<br /><br>- Liver ablation rate<br /><br>- Safety (CTCAE v4.03) and tolerability<br /><br>- Quality of Life</p><br>