Adjuvant Capecitabine vs Gemcitabine Plus Cisplatin in Resected Extrahepatic Cholangiocarcinoma

Sponsor

Asan Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT03079427

Collaborator

Bundang CHA Hospital (Other), Seoul St. Mary's Hospital (Other), Severance Hospital (Other)

100

Enrollment

Location

Arms

70.5

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Anticipated 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

Anticipated Primary Completion Date :

Apr 1, 2021

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

2-year disease-free survival [2 years]
Proportion of patients without disease recurrence after 2 years

Secondary Outcome Measures

Disease-free survival [4 years]
Median time point that 50% of study patients recur
Toxicities (Adverse events related with chemotherapy) [4 years]
Adverse events related with chemotherapy
Overall survival [4 years]
Median time point that 50% of study patients is alive

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.