Intraductal Radiofrequency Thermoablation and Radiotherapy Combined Treatment for Extrahepatic Cholangiocarcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorNational Cancer Center, Korea
About this trial
\[Study objectives\] To evaluate the efficacy and safety of the combined treatment of radiotherapy and endoscopic intraductal radiofrequency ablation in patients with locoregional extrahepatic cholangiocarcinoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients 20 years of age or older, who voluntarily agree to participate in the study and sign the informed consent.
Patients with cytopathologically diagnosed inoperable extrahepatic cholangiocarcinoma
Disqualifiers
Patients who refuse to sign the informed consent
Patients with metastatic cancer (stage IV) or malignant ascites
Patients with intrahepatic cholangiocarcinoma
Patients who are unable to undergo endoscopic procedures as determined by the investigator.
Trial design
Design model
Single group
Treatments tested in this trial
ID-RFA and Radiotherapy
Procedure/SurgeryThe histologic or cytologic examination will be performed at the time of the first biliary drainage, and the extent of the cholangiocarcinoma lesion will be assessed during the procedure. After the diagnosis of extrahepatic cholangiocarcinoma, ID-RFA will be performed, and a biliary stent will be inserted for biliary drainage. Radiotherapy will be performed within 1 month of ID-RFA.
Treatment groups
53 Participants
are divided into 1 treatment groupGroup A: ExperimentalExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
2-year local control rate
2-year local control rate
Time frame
At 2 years from the date of study enrollmentSecondary outcomes
1
1-year local control rate
1-year local control rate
Time frame
At 1 years from the date of study enrollment2
Overall survival
Overall survival
Time frame
The time point of death from any cause from the study enrollment date, whichever occurs first, up to 2 years3
Progression-free survival
Progression-free survival
Time frame
The time point of the date of study enrollment until disease progression or death from any cause, whichever occurs first, up to 2 years4
Local progression-free survival
Local progression-free survival
Time frame
The time point of the date of study enrollment until locoregional progression or death from any cause, whichever occurs first, up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
National Cancer Center, Korea
Lead sponsor
Boston Scientific Corporation
Collaborator
Source ClinicalTrials.gov