Adjuvant Capecitabine vs Gemcitabine Plus Cisplatin in Resected Extrahepatic Cholangiocarcinoma

Asan Medical Center

Status and phase

Completed

Phase 2

Conditions

Adjuvant Chemotherapy

Biliary Tract Cancer

Capecitabine

Gemcitabine

Cholangiocarcinoma

Cisplatin

Treatments

Drug: Gemcitabine plus cisplatin

Drug: Capecitabine

Study type

Interventional

Funder types

Other

Identifiers

NCT03079427

Asan-ONCHBP-2017-001

Details and patient eligibility

About

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.

Enrollment

101 patients

Sex

All

Ages

19+ years old

Volunteers

No 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.