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Gemcitabine+ Capecitabine Vs Capecitabine in Curatively Resected Biliary Tract Cancer

Primary Purpose

Biliary Tract Cancer

Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Gemcitabine/Capecitabine
Capecitabine
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biliary Tract Cancer

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with histologically confirmed adenocarcinoma of biliary tract canacer (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer) after curative intent R0 or R1 surgical resection
  2. Pathologic disease stage of T2-4, N0-2, M0 after surgery, according to AJCC 8th TNM staging
  3. Patients who complete resection (R0 or R1 resection) for biliary tract cancer within 12 weeks of the adjuvant chemotherapy
  4. No distant metastasis
  5. ECOG performance sstatus score of 0 or 1
  6. Age 19 years or older
  7. Adequate bone marrow fuction (neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L and hemoglobin ≥9 g/dL)
  8. Adequate liver function (total bilirubin < 1.5 fold the upper limit of normal of the study site (ULN), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 5.0 x ULN)
  9. Adequate kidney function (Creatinine < 1.5 x ULN)
  10. Unresolved systemic active infection (except for chronic viral hepatitis taking antiviral drugs)
  11. Not receiving other drugs for clinical trials or chemotherapy within 30 days prior to randomization
  12. A female participant who is not post-menopausal or amenorrhea less than 12 consecutive months without specific reasons is eligible to participate if she is not pregnant, confirmed by serum tests within 7 days before the initiation of chemotherapy
  13. The participants provide written informed consent for the study.
  14. No prior chemotherapy for biliary tract cancer
  15. Participants of childbearing potential must agree to use an adequate method of contraception for the course of the study throught 120 days after the last dose of chemotherapy (oral contraceptives or mechanical contraception such as intrauterine devices or contraceptive barriers and etc). Childbearing potential female is who is not post-menopausal or amenorrhea less than 12 consecutive months without specific reasons

Exclusion Criteria:

  1. Other histology type than adenocarcinoma (such as HCC-CCC mixed type or neuroendocrine tumor)
  2. Ampula of vater cancer
  3. Has known additional malignancy (participants with non-melanoma skin cancer, or carcinoma in situ (e.g. breast carcinoma, prostate cancer) that have undergone potentially curative therapy without recurrence for more than 3 years are not excluded)
  4. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  5. Has an active infection requiring systemic therapy (bacteria, virus, fungal, etc)
  6. Has a known history of Human Immunodeficiency Virus (HIV)
  7. Has an active of hepatitis A or B (patients under anti-B-viral treatment with HBV DNA 1000≤copies/ml is allowed to particiapte).
  8. Has a history of severe hemorrhage (gastrointestinal or neurologic) within 2 weeks prior randomization
  9. Is unable to take oral drug due to gastrointestinal obstruction or any other conditions.
  10. Any history of significant cardiac disease within 3 months prior to randomization including unstable angina, NYHA (The New York Heart Association )III or IV congestive heart failure, myocardiac infarction, or severe uncontrolled arrhythmias
  11. Pregnant, breast-feeding or pregnancy test positive female patients
  12. Has any contraindications for investigational drug

    • History of hypersensitivity to capecitabine or gemcitabine
    • Any hypersensitivity to fluorouracil drugs
    • Concurrent administration with sorivudine or brivudine
    • DPD(dihydro-pyridine dehydrogenase) deficiency
    • History of TS-1(tegafur / gimeracil / oteracil) administration
    • Galactose intolerance, Lapp lactase deficince, glucose-galactose malabsorption
    • Interstitial pneumonia or pulmonary fibrosis

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Gemcitabine/Capecitabine

Capecitabine

Arm Description

gemcitabine1,000 mg/m2 over 30 min D1, D8, D15 capecitabine 1660 mg/m2, D1-21

capecitabine 2,500 mg/m2 D1-14

Outcomes

Primary Outcome Measures

Two-year disease free survival (DFS)

Secondary Outcome Measures

Overall Survival (OS)

Full Information

First Posted
May 19, 2020
Last Updated
June 13, 2022
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04401709
Brief Title
Gemcitabine+ Capecitabine Vs Capecitabine in Curatively Resected Biliary Tract Cancer
Official Title
A Randomized, Multi-center Phase III Trial of Adjuvant Chemotherapy With Gemcitabine and Capecitabine Compared to Capecitabine Alone in Curatively Resected Biliary Tract Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
March 30, 2025 (Anticipated)
Study Completion Date
March 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This clinical trial is an open-label, multicenter, phase 3 clinical trial to study the efficacy and safety of adjuvant gemcitabine + capecitabine combination treatment in patients with resectable biliary tract cancer according to imaging studies after surgery. All the patients must complete a consent forms before participating in the clinical trial, and the estimated enrollment period is 36 months after IRB approval. Drug Dose and Schedule: Cohort 1: Gemcitabine/Capecitabine, every 4 weeks, total 6 cycles gemcitabine1,000 mg/m2 over 30 min D1, D8, D15 capecitabine 1660 mg/m2, D1-21 Cohort 2: Capecitabine, everu 3 weeks, total 8 cycles capecitabine 2,500 mg/m2 D1-14
Detailed Description
Study Background & Rationale:adjuvant capecitabine monotherapy following surgery is regarded as standard treatment after phase 3 BILCAP trial, we need further phase 3 clinical trials to evaluate efficacy of doublet combination adjuvant chemotherapy for Biliary Track Cancer after surgery. Since Korea has much higher incidence rate of Biliary Track Cancer compared to western countries, Korea is considered to be a region that can lead large-scale Biliary Track Cancer clinical trials. In this background, we intend to conduct a randomized phase 3 study to compare adjuvant gemcitabine+cisplatin combination therapy with camecitabine monotherapy following curative intent surgical resection in patients with Biliary Track Cancer . Primary Objective: Disease-free survival at 24 months (2-year DFS) Primary Hypothesis: Adjuvant gemcitabine and capecitabine combination treatment confers diseae free survival benefit over capecitabine monotherapy after curative intent surgical resection of biliary tract cancer Study Design: This clinical trial is an open-label, multicenter, phase 3 clinical trial to study the efficacy and safety of adjuvant gemcitabine + capecitabine combination treatment in patients with resectable biliary tract cancer according to imaging studies after surgery. All the patients must complete a consent forms before participating in the clinical trial, and the estimated enrollment period is 36 months after IRB approval.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
490 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gemcitabine/Capecitabine
Arm Type
Experimental
Arm Description
gemcitabine1,000 mg/m2 over 30 min D1, D8, D15 capecitabine 1660 mg/m2, D1-21
Arm Title
Capecitabine
Arm Type
Active Comparator
Arm Description
capecitabine 2,500 mg/m2 D1-14
Intervention Type
Drug
Intervention Name(s)
Gemcitabine/Capecitabine
Intervention Description
gemcitabine 1,000 mg / m2 IV on day 1, 8, and 15 of each cycle Capecitabine 1,660mg / m2 PO twice daily 1 ~ 21 days for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
total 8 cycles Capecitabine 1,250 mg / m2 PO twice daily 1 ~ 14 days for 3 weeks
Primary Outcome Measure Information:
Title
Two-year disease free survival (DFS)
Time Frame
24 months later
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Time Frame
24 months later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with histologically confirmed adenocarcinoma of biliary tract canacer (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer) after curative intent R0 or R1 surgical resection Pathologic disease stage of T2-4, N0-2, M0 after surgery, according to AJCC 8th TNM staging Patients who complete resection (R0 or R1 resection) for biliary tract cancer within 12 weeks of the adjuvant chemotherapy No distant metastasis ECOG performance sstatus score of 0 or 1 Age 19 years or older Adequate bone marrow fuction (neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L and hemoglobin ≥9 g/dL) Adequate liver function (total bilirubin < 1.5 fold the upper limit of normal of the study site (ULN), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 5.0 x ULN) Adequate kidney function (Creatinine < 1.5 x ULN) Unresolved systemic active infection (except for chronic viral hepatitis taking antiviral drugs) Not receiving other drugs for clinical trials or chemotherapy within 30 days prior to randomization A female participant who is not post-menopausal or amenorrhea less than 12 consecutive months without specific reasons is eligible to participate if she is not pregnant, confirmed by serum tests within 7 days before the initiation of chemotherapy The participants provide written informed consent for the study. No prior chemotherapy for biliary tract cancer Participants of childbearing potential must agree to use an adequate method of contraception for the course of the study throught 120 days after the last dose of chemotherapy (oral contraceptives or mechanical contraception such as intrauterine devices or contraceptive barriers and etc). Childbearing potential female is who is not post-menopausal or amenorrhea less than 12 consecutive months without specific reasons Exclusion Criteria: Other histology type than adenocarcinoma (such as HCC-CCC mixed type or neuroendocrine tumor) Ampula of vater cancer Has known additional malignancy (participants with non-melanoma skin cancer, or carcinoma in situ (e.g. breast carcinoma, prostate cancer) that have undergone potentially curative therapy without recurrence for more than 3 years are not excluded) Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. Has an active infection requiring systemic therapy (bacteria, virus, fungal, etc) Has a known history of Human Immunodeficiency Virus (HIV) Has an active of hepatitis A or B (patients under anti-B-viral treatment with HBV DNA 1000≤copies/ml is allowed to particiapte). Has a history of severe hemorrhage (gastrointestinal or neurologic) within 2 weeks prior randomization Is unable to take oral drug due to gastrointestinal obstruction or any other conditions. Any history of significant cardiac disease within 3 months prior to randomization including unstable angina, NYHA (The New York Heart Association )III or IV congestive heart failure, myocardiac infarction, or severe uncontrolled arrhythmias Pregnant, breast-feeding or pregnancy test positive female patients Has any contraindications for investigational drug History of hypersensitivity to capecitabine or gemcitabine Any hypersensitivity to fluorouracil drugs Concurrent administration with sorivudine or brivudine DPD(dihydro-pyridine dehydrogenase) deficiency History of TS-1(tegafur / gimeracil / oteracil) administration Galactose intolerance, Lapp lactase deficince, glucose-galactose malabsorption Interstitial pneumonia or pulmonary fibrosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JoonOh Park, doctor
Phone
82-2-3410-3459
Email
joonoh.park@samsung.com
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joon Oh Park, M.D., Ph.D
Phone
82 2 3410 3459
Email
oncopark@skku.edu
First Name & Middle Initial & Last Name & Degree
yoon Jeong Ahn
Phone
221487395
Ext
82

12. IPD Sharing Statement

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Gemcitabine+ Capecitabine Vs Capecitabine in Curatively Resected Biliary Tract Cancer

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