Table 2.

Inclusion and exclusion criteria

Inclusion criteria

Exclusion criteria

Patients diagnosed with perihilar CCA according to the criteria of the Mayo Clinic, Rochester25: Positive or strongly suspicious intraluminal brush or biopsy A radiographic malignant appearing stricture plus either: CA 19–9 >100 U/mL in the absence of acute bacterial cholangitis Polysomy on FISH A well-defined mass on cross-sectional imaging One tumour mass Unresectable tumour Finished chemotherapy treatment with gemcitabine and cisplatin, preferably eight cycles.* T1–T4 (AJCC staging seventh edition)† before chemotherapy N0–N1 (AJCC staging seventh edition), radiologically or pathologically suspect Measurable disease to be selected as a target on CT/MRI-scan, according to RECIST criteria‡§ Tumour visibility on CT If liver cirrhosis is present, it should be well compensated, with Child-Pugh grade A Age ≥18 years ECOG performance status 0–1 Bilirubin ≤1.5 times normal value, AST/ALT ≤5 times ULN§ Platelets ≥50×109/L, leucocytes >1.5×109/L, haemoglobin >6 mmol/L (9.67g/dL)§ Written informed consent Willing and able to comply to the follow-up schedule Able to start SBRT within 12 weeks after completion of chemotherapy.

Eligibility for resection Prior surgery or transplantation Multifocal tumour Tumour extension in stomach, colon, duodenum, pancreas or abdominal wall N2, (AJCC staging seventh edition), radiologically or pathologically suspect† Distant metastases Progression (local or distant) during or after chemotherapy Ascites Previous radiotherapy to the liver Current pregnancy

*If less cycles have been given, patients are still eligible for this study.

†Before chemotherapy.

‡After chemotherapy.

§Within 6 weeks prior to inclusion.

AJCC, American Joint Committee on Cancer; ALT, alanine transaminase; AST, aspartate transaminase; CCA, cholangiocarcinoma; ECOG-PS, Eastern Cooperative Oncology Group performance status; FISH, fluorescence in situ hybridization; SBRT, stereotactic body radiation therapy.