AROMA - Impact of radioembolization of hepatic malignomas on distal not irradiated tumor tissue.

Completed

Conditions: C20
C19
C18
Malignant neoplasm of rectum
Malignant neoplasm of rectosigmoid junction
Malignant neoplasm of colon

Registration Number: DRKS00009744

Lead Sponsor: Klinik und Poliklinik für Radiologie Klinikum der Universität München Campus Großhadern

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 64

Inclusion Criteria

•hepatic metastatic colorectal carcinoma
•male/female, 18+
•Indication for radioembolization and HDR-brachytherapy in two sessions
•informed consent
•chemotherapy break for at least 2 weeks before inclusion
•no corticosteroides for at least 2 weeks before inclusion

Exclusion Criteria

•life expectancy < 3 month
•extrahepatic tumor manifestation
•hepatic tumorload > 70%
•chronic infections
•ascites
•contraindication for angiography, MRI contrast media, X-ray contrast media, MRI and CT
•liver cirrhosis
•condition after resection of the papilla vateri or DHC stenting
•cardio vascular disease (NYHA III/IV)
•thrombotic/embolic episodes (stroke)
•severe hemorrhages within last 3 month
•secondary malignoma within last 5 years
•immune suppressive therapy or disease (e.g. condition after organ transplantation, HIV, corticosteroides)
•autoimmune disease or inflammatory bowel disease

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of the amount of tumor infiltrating lymphocytes before and 4-8 weeks after radioembolization of hepatic tumors in not yet treated tumor sites. <br><br>Determination of the level of systemcally released growth factors after radioembolization of hepatic tumors and correlation with growth tendency of not yet treated tumor parts in the treatment free intervall between radioembolization and brachytherapy.

Secondary Outcome Measures