Adjuvant Capecitabine vs Gemcitabine Plus Cisplatin in Resected Extrah

Not Yet Open.

Adjuvant Capecitabine vs Gemcitabine Plus Cisplatin in Resected Extrahepatic Cholangiocarcinoma

Purpose
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 Intervention Phase
Cholangiocarcinoma
Biliary Tract Cancer
Adjuvant Chemotherapy
Capecitabine
Gemcitabine
Cisplatin
Drug: Gemcitabine plus cisplatin
Drug: Capecitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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

Resource links provided by NLM:

Genetics Home Reference related topics: cholangiocarcinoma
Drug Information available for: Cisplatin Gemcitabine Gemcitabine hydrochloride Capecitabine
Genetic and Rare Diseases Information Center resources: Biliary Tract Cancer
U.S. FDA Resources

Further study details as provided by Asan Medical Center:

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

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

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

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

Estimated Enrollment: 100
Anticipated Study Start Date: April 2017
Estimated Study Completion Date: April 2022
Estimated Primary Completion Date: April 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Gemcitabine and cisplatin

Eligibility

Ages Eligible for Study: 19 Years and older (Adult, Senior)
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Seoul, Korea, Republic of, 05505
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Baek-Yeol Ryoo, MD Asan Medical Center
More Information

Publications:
Horgan AM, Amir E, Walter T, Knox JJ. Adjuvant therapy in the treatment of biliary tract cancer: a systematic review and meta-analysis. J Clin Oncol. 2012 Jun 1;30(16):1934-40. doi: 10.1200/JCO.2011.40.5381. Review.
Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators.. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. doi: 10.1056/NEJMoa0908721.
Ramírez-Merino N, Aix SP, Cortés-Funes H. Chemotherapy for cholangiocarcinoma: An update. World J Gastrointest Oncol. 2013 Jul 15;5(7):171-6. doi: 10.4251/wjgo.v5.i7.171.
Neoptolemos JP, Moore MJ, Cox TF, Valle JW, Palmer DH, McDonald AC, Carter R, Tebbutt NC, Dervenis C, Smith D, Glimelius B, Charnley RM, Lacaine F, Scarfe AG, Middleton MR, Anthoney A, Ghaneh P, Halloran CM, Lerch MM, Oláh A, Rawcliffe CL, Verbeke CS, Campbell F, Büchler MW; European Study Group for Pancreatic Cancer.. Effect of adjuvant chemotherapy with fluorouracil plus folinic acid or gemcitabine vs observation on survival in patients with resected periampullary adenocarcinoma: the ESPAC-3 periampullary cancer randomized trial. JAMA. 2012 Jul 11;308(2):147-56. doi: 10.1001/jama.2012.7352. Erratum in: JAMA. 2012 Nov 14;308(18):1861.
Patt YZ, Hassan MM, Aguayo A, Nooka AK, Lozano RD, Curley SA, Vauthey JN, Ellis LM, Schnirer II, Wolff RA, Charnsangavej C, Brown TD. Oral capecitabine for the treatment of hepatocellular carcinoma, cholangiocarcinoma, and gallbladder carcinoma. Cancer. 2004 Aug 1;101(3):578-86.
Petekkaya I, Gezgen G, Roach EC, Solak M, Gullu I. Long-term advanced cholangiocarcinoma survivor with single-agent capecitabine. J BUON. 2012 Oct-Dec;17(4):796.

Responsible Party: Baek-Yeol Ryoo, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03079427 History of Changes
Other Study ID Numbers: Asan-ONCHBP-2017-001
Study First Received: March 9, 2017
Last Updated: March 13, 2017
Individual Participant Data
Plan to Share IPD: No

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