SIRT Followed by CIS-GEM Chemotherapy Versus CIS-GEM Chemotherapy Alone as 1st Line Treatment of … (NCT02807181) | Clinical Trial Compass
TerminatedPhase 2/3
SIRT Followed by CIS-GEM Chemotherapy Versus CIS-GEM Chemotherapy Alone as 1st Line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma
Stopped: Slow enrollment
United States, Australia, Belgium89 participantsStarted 2017-02-14
Plain-language summary
The study planned to 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 were randomized to CIS-GEM chemotherapy plus SIRT, and half of the patients were randomized to CIS-GEM alone.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 naĂŻve. 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 surgicall…
What they're measuring
1
Survival at 18 Months
Timeframe: 18 months following the date of randomization.