A pilot study to determine the feasibility of Stereotactic Body Radiation Therapy following Chemotherapy for Unresectable perihilar CholangioCarcinoma

Recruiting

• Conditions: cholangiocarcinoma; perihilar; 10019815

• Registration Number: NL-OMON45647
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

-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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of this study is feasibility measured by radiotherapy<br /><br>induced toxicity according to CTC v4.0.3.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p> -Quality of life<br /><br>-Local progression<br /><br>-Progression free survival<br /><br>-Overall survival<br /><br>-Cellular radiosensitivity. </p><br>