Adjuvant Capecitabine vs Gemcitabine Plus Cisplatin in Resected Extrahepatic Cholangiocarcinoma

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 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

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