The objective of this study is to evaluate the efficacy of stereotactic body radiation therapy (SBRT) as additional treatment after standard chemotherapy regarding tumor local control, toxicity, progression-free survival (PFS), overall survival and quality of life. In addition, the objective is to explore the value of immunodynamics in peripheral blood for predicting PFS in patients undergoing chemotherapy.
Perihilar cholangiocarcinoma (pCCA) according to the criteria of the Mayo Clinic, Rochester: a positive or strongly suspicious intraluminal brush cytology or biopsy, or a radiographic malignant appearing stricture plus either: CA 19-9>100 U/ml in the absence of acute bacterial cholangitis, or polysomy on fluorescence in situ hybridization (FISH), or a well-defined mass on cross sectional imaging
One tumor mass
Unresectable tumor or patient deemed unfit for surgery
T1-T4 (AJCC staging 8th edition), N0-N2-M0 (AJCC staging 8th edition), radiologically or pathologically suspect. N1 is defined as one to three affected lymph nodes typically involving the hilar, cystic duct, common bile duct, hepatic artery, posterior pancreatoduodenal, and portal vein lymph nodes. N2 is defined as four or more affected lymph nodes from the sites described for N1. Endoscopic ultrasound (EUS) is leading in identifying pathological lymph nodes compared to CT.
Prior surgery or transplantation of the liver
Tumor extension in stomach, colon, duodenum, pancreas or abdominal wall
Ascites
Prior radiotherapy to the liver
Single group
Stereotactic body radiation therapy
RadiationSBRT will be delivered in 15 fractions of 4 to 4.5Gy (risk-adapted), one fraction each weekday for 3 weeks.
Local tumor control
Local tumor control is defined as time from inclusion to local radiological progression. Definition of progression is based on response evaluation criteria in solid tumors (RECIST) 1.1. In RECIST 1.1, response of a tumor to treatment is defined as either complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).
Progression-free survival (PFS)
PFS is defined as time from inclusion until radiological progression. Definition of progression is based on RECIST 1.1.
Overall survival (OS)
OS is defined as time from inclusion until death from any cause.
Adverse events
Adverse events assessed by the Common Toxicity Criteria for Adverse Events (CTCAE) V.5.0
Biliary stent-related events (SRE)
The definition of SRE in this study is based on the definition used in the study by Lamarca et al. (https://doi.org/10.3748/wjg.v22.i26.6065). A SRE is defined as any one or more of the following: 1. any episode of jaundice which is considered significant enough for new stenting or medical treatment and is confirmed by radiological imaging to be associated with biliary dilatation; 2. any episode of infection which is clinically in keeping with cholangitis (bile duct infection) requiring antibiotic therapy; 3. bacteraemia with isolation in blood cultures of bacteria suspected to have originated in the biliary tract; and 4. any episode of cholecystitis or gallbladder perforation.
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Erasmus Medical Center
Lead sponsor
Dutch Cancer Society
Collaborator
