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

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

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•- 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.

•-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
•-Previous radiotherapy to the liver;
•-Current pregnancy

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