Status:
COMPLETED
Stereotactic Body Radiation Therapy for Unresectable Perihilar Cholangiocarcinoma
Lead Sponsor:
Erasmus Medical Center
Conditions:
Klatskin Tumor
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Rationale: For patients with perihilar cholangiocarcinoma, surgery is the only treatment modality that can result in cure. Unfortunately, in the majority of these patients the tumors are found to be ...
Detailed Description
For patients with perihilar cholangiocarcinoma, surgery is the only treatment modality that can result in cure. Unfortunately, in the majority of these patients the tumors are found to be unresectable...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- In order to be eligible to participate in this study, a subject must be discussed in a multidisciplinary liver tumor board and should meet all of the following criteria:
- Patients diagnosed with perihilar cholangiocarcinoma according to the criteria of the Mayo Clinic, Rochester:
- 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:
- 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
Exclusion
Key Trial Info
Start Date :
November 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03307538
Start Date
November 6 2017
End Date
June 30 2020
Last Update
January 26 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Erasmus MC
Rotterdam, South Holland, Netherlands, 3015 CE