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NCT03079427 · CITED IN SOURCE DOCUMENTS

Adjuvant Capecitabine vs Gemcitabine Plus Cisplatin in Resected Extrahepatic Cholangiocarcinoma

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2022-12-06

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
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.
healthy Volunteers
false
minimum Age
19 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Adjuvant Capecitabine
    intervention Names
    1. Drug: Capecitabine
    label
    Capecitabine
    type
    ACTIVE_COMPARATOR
  2. description
    Adjuvant Gemcitabine plus Cisplatin
    intervention Names
    1. Drug: Gemcitabine plus cisplatin
    label
    Gemcitabine plus cisplatin
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Gemcitabine plus cisplatin
    description
    Gemcitabine 1,000 mg/m2 and cisplatin 25 mg/m2 Day 1 and 8, every 3 weeks
    name
    Gemcitabine plus cisplatin
    other Names
    1. Gemcitabine
    2. Cisplatin
    type
    DRUG
  2. arm Group Labels
    1. Capecitabine
    description
    Capecitabine 1,250 mg/m2 Day 1 to 14, every 3 weeks
    name
    Capecitabine
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
101
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Proportion of patients without disease recurrence after 2 years
    measure
    2-year disease-free survival
    time Frame
    2 years
secondary Outcomes
  1. description
    Median time point that 50% of study patients recur
    measure
    Disease-free survival
    time Frame
    4 years
  2. description
    Adverse events related with chemotherapy
    measure
    Toxicities (Adverse events related with chemotherapy)
    time Frame
    4 years
  3. description
    Median time point that 50% of study patients is alive
    measure
    Overall survival
    time Frame
    4 years
Full 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.
Source references
references
  1. citation
    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. Epub 2012 Apr 23.
    pmid
    22529261
    type
    BACKGROUND
  2. citation
    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.
    pmid
    20375404
    type
    BACKGROUND
  3. citation
    Ramirez-Merino N, Aix SP, Cortes-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.
    pmid
    23919111
    type
    BACKGROUND
  4. citation
    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, Olah A, Rawcliffe CL, Verbeke CS, Campbell F, Buchler 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.
    pmid
    22782416
    type
    BACKGROUND
  5. citation
    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. doi: 10.1002/cncr.20368.
    pmid
    15274071
    type
    BACKGROUND
  6. citation
    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. No abstract available.
    pmid
    23335544
    type
    BACKGROUND
  7. citation
    Jeong H, Oh JH, Ahn HS, Ryoo BY, Kim KP, Jeong JH, Park I, Hwang DW, Lee JH, Song KB, Lee W, Kim KH, Moon DB, Song GW, Jung DH, Hong SM, Park CW, Baek IP, Cho YS, Kim K, Sung CO, Yoo C. Proteogenomic profiling predicts outcomes of adjuvant chemotherapy in extrahepatic cholangiocarcinoma. J Hepatol. 2026 Jan;84(1):122-134. doi: 10.1016/j.jhep.2025.07.031. Epub 2025 Aug 11.
    pmid
    40803577
    type
    DERIVED
  8. citation
    Yoo C, Jeong H, Jeong JH, Kim KP, Lee S, Ryoo BY, Hwang DW, Lee JH, Moon DB, Kim KH, Lee SS, Song TJ, Oh D, Lee MA, Chon HJ, Lee JS, Laliotis G, Rivero-Hinojosa S, Spickard E, Renner D, Dutta P, Palsuledesai CC, Sharma S, Malhotra M, Jurdi A, Liu MC. Circulating tumor DNA status and dynamics predict recurrence in patients with resected extrahepatic cholangiocarcinoma. J Hepatol. 2025 May;82(5):861-870. doi: 10.1016/j.jhep.2024.10.043. Epub 2024 Nov 10.
    pmid
    39532185
    type
    DERIVED
Source notices and limitations
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        rence in the period after 24 months (HR, 1.57; 95% CI, 0.90&#8211;2.74).</li></ul></div></li><li> The open-label, randomized, phase II <a href="/clinicaltrials/NCT03079427">STAMP</a> study (NCT03079427), presented in abstract form, included 101 patients with perihilar or distal bile duct cancer, at least one regional lymph node m
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        onths (HR, 1.57; 95% CI, 0.90&#8211;2.74).</li></ul></div></li><li> The open-label, randomized, phase II <a href="/clinicaltrials/NCT03079427">STAMP</a> study (NCT03079427), presented in abstract form, included 101 patients with perihilar or distal bile duct cancer, at least one regional lymph node metastasis (N1 or greater), and
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      Bile Duct Cancer (Cholangiocarcinoma) Treatment (PDQ®)–Health Professional Version
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      1. context
        Updated: March 28, 2025
        datetime
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        display
        March 28, 2025

    Preserved source evidence · Not medical advice