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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
2-year disease-free survival
Secondary Outcome
Disease-free survival
Condition
Cholangiocarcinoma
Intervention
Gemcitabine plus cisplatin
Study Arms / Comparison Groups
Capecitabine
Description: Adjuvant Capecitabine
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
May 15, 2017
Completion Date
April 2023
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 < 100 U/mL at the time of enrollment - Adequate bone marrow function as defined by platelets ≥ 100 x 109/L and neutrophils ≥ 1.5 x 109/L - Adequate renal function, with serum creatinine < 1.5 x upper limit of normal (ULN) - Adequate hepatic function with serum total bilirubin < 2 mg/dL, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 2.5 x ULN - No other malignant disease apart from non-melanotic skin cancer or carcinoma in situ of the uterine cervix or any other non life-threatening cancer (i.e., prostate or thyroid cancer) except where treated with curative intent > 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 (< 1% per year) when used consistently and correctly.
Gender
All
Ages
19 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Baek-Yeol Ryoo, MD, +82-2-3010-1727, [email protected]
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT03079427
Organization ID
Asan-ONCHBP-2017-001
Responsible Party
Principal Investigator
Study Sponsor
Asan Medical Center
Collaborators
Bundang CHA Hospital
Study Sponsor
Baek-Yeol Ryoo, MD, Principal Investigator, Asan Medical Center
Verification Date
June 2020