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Adjuvant Capecitabine vs Gemcitabine Plus Cisplatin in Resected Extrahepatic Cholangiocarcinoma

Descriptive Information
Brief Title † Adjuvant Capecitabine vs Gemcitabine Plus Cisplatin in Resected Extrahepatic Cholangiocarcinoma
Official Title † Randomized Phase 2 Study of Capecitabine vs Gemcistabine Plus Cisplatin in Patients With Resected Extrahepatic Cholangiocarcinoma With Regional Lymph Node Metastasis
Brief Summary There is no proven adjuvant treatment after curative surgical resection in patients with cholangiocarcinoma, although previous meta-analysis suggested potential survival benefit of adjuvant chemotherapy or radiotherapy in patients with lymph node-positive resected cholangiocarcinoma. Despite of lack of level 1 evidence and no data which regimen is optimal, adjuvant chemotherapy is widely used in daily practice setting. Based on this background, the investigators designed the randomized phase 2 trial comparing capecitabine and gemcitabine plus cisplatin in patients with resected lymph node-positive extrahepatic cholangiocarcinoma.
Detailed Description
Study Phase Phase 2
Study Type † Interventional
Study Design †
Primary Outcome Measure † 2-year disease-free survival
Secondary Outcome Measure † Disease-free survival
Condition † Cholangiocarcinoma Biliary Tract Cancer Adjuvant Chemotherapy Capecitabine Gemcitabine Cisplatin
Intervention † DrugGemcitabine plus cisplatin
Study Arms / Comparison Groups Capecitabine Adjuvant Capecitabine Gemcitabine plus cisplatin Adjuvant Gemcitabine plus Cisplatin
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 100
Start Date † April 2017
Completion Date April 2022
Primary Completion Date April 2021
Eligibility Criteria † Inclusion Criteria: - Patients aged 19 years and older - Histologically documented extrahepatic cholangiocarcinoma (perihilar or distal bile duct tumor) - Microscopic or macroscopic surgical resection (ie., R0 or R1 resection) - Regional lymph node metastasis according to the American Joint Committee on Cancer (AJCC) 7th edition - No distant metastasis - Eastern Cooperative Oncology Group (ECOG) performance status 0 ~ 1 - No prior chemotherapy or radiotherapy - Serum CA 19-9 5 years previously without evidence of relapse Written informed consent to the study Exclusion Criteria: - Medical or psychiatric conditions that compromise the patient's ability to give informed consent or to complete the protocol or a history of non-compliance - Histologies other than adenocarcinoma such as mixed hepatocellular carcinoma/cholangiocarcinoma, adenosquamous carcinoma or mixed adenocarcinoma/neuroendocrine carcinoma - Intrahepatic cholangiocarcinoma or gallbladder cancer - Obstruction of gastrointestinal tract - Active gastrointestinal bleeding - Myocardial infarction within 6 months prior to the study medication, and other clinically significant heart disease (e.g., unstable angina, congestive heart failure or uncontrolled hypertension) - Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardise compliance with the protocol - Female subjects who are pregnant or lactating, or males and females of reproductive potential not willing or not able to employ a highly effective method of birth control/contraception to prevent pregnancy from 2 weeks before receiving study drug until 3 months after receiving the last dose of study drug. A highly effective method of contraception is defined as having a low failure rate (
Gender All
Ages 19 Years - N/A
Accepts Healthy Volunteers No
Contacts †† Chanhoon Yoo, MD, +82-2-3010-1727, yooc@amc.seoul.kr
Location Countries † Korea, Republic of
Administrative Information
NCT ID † NCT03079427
Organization ID Asan-ONCHBP-2017-001
Secondary IDs ††
Responsible Party Principal Investigator
Study Sponsor † Asan Medical Center
Collaborators ††
Investigators † Principal Investigator: Baek-Yeol Ryoo, MD, Asan Medical Center
Information Provided By
Verification Date March 2017
First Received Date † March 9, 2017
Last Updated Date March 13, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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