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Adjuvant Capecitabine vs Gemcitabine Plus Cisplatin in Resected Extrahepatic Cholangiocarcinoma

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ClinicalTrials.gov Identifier: NCT03079427
Recruitment Status : Recruiting
First Posted : March 14, 2017
Last Update Posted : September 19, 2017
Sponsor:
Information provided by (Responsible Party):
Baek-Yeol Ryoo, Asan Medical Center

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.

Condition or disease Intervention/treatment Phase
Cholangiocarcinoma Biliary Tract Cancer Adjuvant Chemotherapy Capecitabine Gemcitabine Cisplatin Drug: Gemcitabine plus cisplatin Drug: Capecitabine Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase 2 Study of Capecitabine vs Gemcistabine Plus Cisplatin in Patients With Resected Extrahepatic Cholangiocarcinoma With Regional Lymph Node Metastasis
Actual Study Start Date : May 15, 2017
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2022


Arm Intervention/treatment
Active Comparator: Capecitabine
Adjuvant Capecitabine
Drug: Capecitabine
Capecitabine 1,250 mg/m2 Day 1 to 14, every 3 weeks

Experimental: Gemcitabine plus cisplatin
Adjuvant Gemcitabine plus Cisplatin
Drug: Gemcitabine plus cisplatin
Gemcitabine 1,000 mg/m2 and cisplatin 25 mg/m2 Day 1 and 8, every 3 weeks
Other Names:
  • Gemcitabine
  • Cisplatin




Primary Outcome Measures :
  1. 2-year disease-free survival [ Time Frame: 2 years ]
    Proportion of patients without disease recurrence after 2 years


Secondary Outcome Measures :
  1. Disease-free survival [ Time Frame: 4 years ]
    Median time point that 50% of study patients recur

  2. Toxicities (Adverse events related with chemotherapy) [ Time Frame: 4 years ]
    Adverse events related with chemotherapy

  3. Overall survival [ Time Frame: 4 years ]
    Median time point that 50% of study patients is alive



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03079427


Contacts
Contact: Chanhoon Yoo, MD +82-2-3010-1727 yooc@amc.seoul.kr

Locations
Korea, Republic of
Asan Medical Center, University of Ulsan College of Medicine Recruiting
Seoul, Korea, Republic of, 05505
Contact: Changhoon Yoo, MD    +82-2-3010-1727    yooc@amc.seoul.kr   
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Baek-Yeol Ryoo, MD Asan Medical Center

Publications:

Responsible Party: Baek-Yeol Ryoo, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03079427     History of Changes
Other Study ID Numbers: Asan-ONCHBP-2017-001
First Posted: March 14, 2017    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Baek-Yeol Ryoo, Asan Medical Center:
Cholangiocarcinoma
Adjuvant chemotherapy

Additional relevant MeSH terms:
Cholangiocarcinoma
Biliary Tract Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Gemcitabine
Cisplatin
Capecitabine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs