Irresectable intrahepatic cholangiocellular carcinoma: Evaluation of the Efficacy of multimodal treatment by interstitial HDR-Brachytherapy combined with Gemcitabine/Cisplatin Chemotherapy

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00007161
• Date of registration: 10/08/2016
• Prospective Registration: No
• Primary sponsor: Universitätsklinikum Magdeburg
• Public title: Irresectable intrahepatic cholangiocellular carcinoma: Evaluation of the Efficacy of multimodal treatment by interstitial HDR-Brachytherapy combined with Gemcitabine/Cisplatin Chemotherapy
• Scientific title: Irresectable intrahepatic cholangiocellular carcinoma: Evaluation of the Efficacy of multimodal treatment by interstitial HDR-Brachytherapy combined with Gemcitabine/Cisplatin Chemotherapy - CHOICE II
• Date of first enrolment: 15/11/2012
• Target sample size: 50
• Recruitment status: Recruiting
• URL: http://drks.de/search/en/trial/DRKS00007161
• Study type: observational
• Study design: Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: treatment

Countries of recruitment

Germany

Contacts

• Name: Jens Ricke
• Affiliation: Klinik und Poliklinik für Radiologie Klinikum der Universität München Campus Großhadern

• Name: Susanne Penzlin
• Affiliation: Klinik für Radiologie und Nuklearmedizin

Key inclusion & exclusion criteria

Inclusion criteria: histologically confirmed cholangiocellular carcinoma
intrahepatic localization of a massforming CCC
whole tumor bound of the liver not > 50%
at least 1 lesion is accessible to an interventional therapy
consent and ability to all study specific actions voluntary, informed and personally written consent
Patient Age not under 18 and not over 85 years
suitable cardiac, renal and haematological parameters
Exclusion criteria: pregnant or breast-feeding women respectively possible pregnancy
uncontrolled ascites
other tumor diseases within the last 5 years (expect carcinoma in situ of the skin or zervix)
uncooperative/noncompliant
already participant of this study
participation on another therapy study
contraindication for Primovist-MRI or contrast-CT
moderate or graved renal failure (GFR < 60 ml/min) appropriate to laboratory values 1 week before Primovist-MRI
previous Radiation of the liver
to clinic or investigator related patients
acute or risk of acute severe bleeding (WHO grade 3-4)
upper gastrointestinal bleeding in the last 3 month
thrombembolic events including TIA in the last 6 month
uncontrolled hypertonus
life expactancy under 16 weeks
state by orgn transplantation
congenital immune defects
immunsuppressive therapie in case of autoimmune disease or chronic inflammatory disease



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

C22.1

C22.1

Intrahepatic bile duct carcinoma

Intervention(s)

Group 1: 1. Screening:
History, ECOG evaluation (to assess how the disease your need for life skills affected), EuroQoL-5D, a pregnancy test in patients of childbearing age, circulatory parameters, blood, urinalysis, CT or MRI for initial evaluation and, if necessary biopsy

Preprocedure, an EGD, colonoscopy, an echocardiogram, an EKG, a 3-phase CT of the chest and abdomen and a Primovist-enhanced MRI of the liver can be performed.

2. Treatment:
Depending on the tumor size and feasibility, first patients receive one or more local radiation therapy of liver tumors (single or two-stage or fractionated). Here percutaneous catheters are inserted into the liver tumors under sedation. Irradiation takes place through the indwelling catheter using iridium source. Then the catheter is removed, the patient still monitor surveillance few hours and they have to hospitalization.
After completion of the local radiation therapy, the gold standard chemotherapy using gemcitabine and cisplatin is done by the respective treating oncologist. Here, a chemotherapy cycle contains 15 days; on Day 22 starts a new cycle. On days 1 and 8 outpatient chemotherapy with laboratory control, on Day 15, only a blood test done. Patients will receive the basic inital doses of 1000 mg / m2 Gemzar and 25 mg / m2 cisplatin. For this purpose there is a pre-medication with 3000ml of 0.9% NaCl solution i.v. about 3-6h with ondansetron 8 mg i.v. i.v. (Day 1), 150 mg of aprepitant i.v. (Day 1) and 8 mg dexamethasone (Days 1 and 8). In addition, patients received 250 ml of 10% mannitol i.v. over 15 minutes before and after cisplatin and 2x Dexmathason 4 mg orally on days 2-4 and 9-11.
Individual adjustment of doses is up to the treating oncologist in incompatibilities or side effects. Like

Primary Outcome(s)

Progression free survival (follow-up time is planed until death of the patient or one year after the inclusion of the last study-patient)

Secondary Outcome(s)

time to uncontrolled local Progression, Overall survival, Quality of life (EQ-5D) (to be completed at time of inclusion, at brachytherapy and at follow up visits every 3 months)

Secondary ID(s)

LMU-RAD00007

2008-001316-21

RAD47

Source(s) of Monetary Support

Klinik und Poliklinik für Radiologie Klinikum der Universität München Campus Großhadern

Klinik für Radiologie und NuklearmedizinUniversität Magdeburg

Ethics review

Status: Approved
Approval date: 05/07/2012
Contact:

[e-mail]

Ethik-Kommission der Otto-von-Guericke-Universität an der Medizinischen Fakultät und am Universitätsklinikum Magdeburg A.ö.R.

[phone]

[e-mail]

Results

• URL: http://drks.de/search/en/trial/DRKS00007161#studyResults