cholangiocarcinoma perihilar
Conditions
Interventions
SBRT will be delivered in 15 fractions of 3 to 4.5Gy after 8 cycles of
chemotherapy. In case of toxicity causing premature termination of systemic
treatment, the patient can still proceed to SBRT.
cholangiocarcinoma
feasibility
quality of life
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Patients diagnosed with perihilar cholangiocarcinoma according to the criteria of the Mayo Clinic: -Positive or strongly suspicious intraluminal brush 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 FISH, or -a well-defined mass on cross sectional imaging -One tumor mass ; -Unresectable tumor; -Finished chemotherapy treatment with Gemcitabine and Cisplatin, preferably 8 cycles; If less cycles are given, patients are still eligible for this study. -T1-T4 (AJCC staging 7th edition), before chemotherapy; -N0-N1 (AJCC staging 7th edition), radiologically or pathologically suspect, before chemotherapy; -Measurable disease to be selected as a target on CT/MRI-scan, according to RECIST criteria, after chemotherapy within 6 weeks prior to inclusion -Tumor 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, within 6 weeks prior to inclusion; -Platelets * 50x10E9/ l, Leukocytes > 1.5x10E9/l, Hb > 6 mmol/l, within 6 weeks prior to inclusion; -Written informed consent, after chemotherapy; -Willing and able to comply to the follow-up schedule; -Able to start SBRT within 12 weeks after completion of chemotherapy.
Exclusion criteria
Exclusion criteria: -Eligibility for resection; -Prior surgery or transplantation; -Multifocal tumor; -Tumor extension in stomach, colon, duodenum, pancreas or abdominal wall; -N2, (AJCC staging 7th edition), radiologically or pathologically suspect, before chemotherapy; -Distant metastases; -Progression (local or distant) during or after chemotherapy -Ascites; -Previous radiotherapy to the liver; -Current pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is feasibility measured by radiotherapy induced toxicity according to CTC v4.0.3. | — |
Secondary
| Measure | Time frame |
|---|---|
| -Quality of life -Local progression -Progression free survival -Overall survival -Cellular radiosensitivity. | — |
Countries
The Netherlands
Outcome results
None listed