Trial purpose
Cancer treatment
Tumor type
Upper gastrointestinal tract
Age
18+
Clinical summary
Summary
The study will evaluate the benefit of applying Selective Internal Radiation Therapy (SIRT) using SIR-Spheres Y-90 resin microspheres prior to receiving systemic chemotherapy treatment (cisplatin-gemcitabine, or CIS-GEM) in patients with unresectable intrahepatic cholangiocarcinoma. Half of the patients will be randomized to CIS-GEM chemotherapy plus SIRT, and half of the patients will be randomized to CIS-GEM alone. Randomized patients will be followed until death, withdrawal of consent, or until end of study.
Conditions
This trial is treating people with Intrahepatic Cholangiocarcinoma
Eligibility
Inclusion
- Willing, able and mentally competent to provide written informed consent.
- Aged 18 years or older.
- Histologically or cytologically confirmed unresectable and non-ablatable intrahepatic cholangiocarcinoma.
- Liver-only or liver predominant intrahepatic cholangiocarcinoma. Patient are permitted to have loco-regional lymph node involvement defined as: portal LN </= to 2 cm and/or para aortic LN </= to 1.5 cm in longest diameter, and/or up to 2 indeterminate lung lesions < 1 cm if these lung lesions are positron emission tomography (PET) negative.
- Chemotherapy naïve. Adjuvant chemotherapy is not permitted.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Adequate hematological function defined as:
Hemoglobin >/= 10g/dL White Blood Cell count (WBC) >/= 3.0 x 10^9/L Absolute neutrophil count (ANC) >/= 1.5 x 10^9/L Platelet count >/= 100,000/mm^3 - Adequate liver function defined as: Total bilirubin </= 30 umol/L (1.75 mg/dL) Albumin >/= 30 g/L
- 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)
- Life expectancy of at least 3 months without any active treatment
- 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.
- Male patients must be surgically sterile or if sexually active must use an acceptable method of contraception during the study.
- Considered suitable to receive either regimen in the clinical judgement of the treating investigator.
Exclusion
- Patients with only non-measurable lesions in the liver according to RECIST criteria
- Incomplete recovery from previous liver surgery, e.g. unresolved biliary tree obstruction or biliary sepsis or inadequate liver function
- Biliary stent in situ
- Main trunk Portal Vein Thrombosis (PVT)
- Ascites, even if controlled with diuretics. (A minor peri-hepatic rim of ascites detected at imaging is acceptable).
- Mixed hepatocellular carcinoma - intrahepatic cholangiocarcinoma (HCC-ICC) disease
- 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 1) malignancy adequately resected with curative intent at least 5 years prior to study entry
- Suspicion of any bone metastasis/metastases or central nervous system metastasis/metastases on clinical or imaging examination.
- Prior internal or external radiation delivered to the liver.
- Pregnancy; breast feeding.
- Participation within 28 days prior to randomization, in an active part of another clinical study that would compromise any of the endpoints of the study.
- Evidence of ongoing active infection that may affect treatment feasibility or outcome.
- Prior Whipple's procedure.
Inclusion
- You have been diagnosed with cancer, but have not received any treatment.
- Your cancer has not spread to other parts of the body (localised).
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
- You are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Sirtex Medical Limited
Scientific Title
Prospective, Multicenter, Randomized, Controlled Study Evaluating SIR-Spheres Y-90 Resin Microspheres Preceding Cisplatin-gemcitabine (CIS-GEM) Chemotherapy Versus CIS-GEM Chemotherapy Alone as First-line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma
Get Support
You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.
Know more about Peer Connect
If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.
Get support
Learn more about clinical trials through this collection of resources in languages other than English.
View information