Status Approved
First Submitted Date
2020/05/20
Registered Date
2020/05/26
Last Updated Date
2020/05/25
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0005056 |
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Unique Protocol ID | SMC 2020-01-101 |
Public/Brief 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 |
Scientific 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 |
Acronym | GEM_XELODA_ADJ |
MFDS Regulated Study | Yes |
IND/IDE Protocol | No |
Registered at Other Registry | Yes |
Name of Registry / Registration Number | ClinicalTrials.gov-NCT04401709 |
Healthcare Benefit Approval Status | Submitted pending |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | SMC-2020-01-101-002 |
Approval Date | 2020-04-18 |
Institutional Review Board Name | Samsung medical center Institutional Review Board |
Institutional Review Board Address | 81, Irwon-ro, Gangnam-gu, Seoul |
Institutional Review Board Telephone | 02-3410-2973 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | JoonOh Park |
Title | PhMD |
Telephone | +82-2-2148-7394 |
Affiliation | Samsung Medical Center |
Address | 81, Irwon-ro, Gangnam-gu, Seoul |
Contact Person for Public Queries | |
Name | JoonOh Park |
Title | PhMD |
Telephone | +82-2-2148-7394 |
Affiliation | Samsung Medical Center |
Address | 81, Irwon-ro, Gangnam-gu, Seoul |
Contact Person for Updating Information | |
Name | JoonOh Park |
Title | PhMD |
Telephone | +82-2-2148-7394 |
Affiliation | Samsung Medical Center |
Address | 81, Irwon-ro, Gangnam-gu, Seoul |
4. Status
Study Site | Multi-center Number of center : 2 | |
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Overall Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2020-08-01 Anticipated | |
Target Number of Participant | 490 | |
Primary Completion Date | 2025-03-30 , Anticipated | |
Study Completion Date | 2025-03-30 , Anticipated | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Samsung Medical Center | |
Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2020-08-01 , | |
Recruitment Status by Participating Study Site 2 | ||
Name of Study | Yonsei University Health System, Severance Hospital | |
Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2020-08-01 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Ildong pharmaceutical |
Organization Type | Pharmaceutical Company |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Samsung Medical Center |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | 1. 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+capecitabine combination therapy with capecitabine monotherapy following curative intent surgical resection in patients with Biliary Track Cancer . 2. Primary Objective: - Disease-free survival at 24 months (2-year DFS) 3. 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 4. 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. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Treatment |
Phase | Phase3 |
Intervention Model | Parallel |
Blinding/Masking | Open |
Allocation | RCT |
Intervention Type | Drug |
Intervention Description | • Cohort 1: One cycle repeats every 4 weeks. 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 total 6cycles • Cohort 2: One cycle repeats every 3weeks. Capecitabine 1,250 mg/m2 PO twice daily 1 ~ 14 days for 3 weeks total 8 cycles |
Number of Arms | 2 |
Arm 1 |
Arm Label gemcitabine/capecitabine |
Target Number of Participant 245 |
|
Arm Type Experimental |
|
Arm 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 |
|
Arm 2 |
Arm Label capecitabine |
Target Number of Participant 245 |
|
Arm Type Active comparator |
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Arm Description Capecitabine 1,250 mg/m2 PO twice daily 1 ~ 14 days for 3 weeks |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (C00-D48)Neoplasms (C24.9)Malignant neoplasm of biliary tract, unspecified R0 or R1 resected T2-4N0-2M0 biliary tract cancer (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma and gallbladder cancer) |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 19Year~No Limit |
|
Description 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. |
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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 |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | 24 months disease-free survival(DFS) |
|
Timepoint | 24 months later |
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Secondary Outcome(s) 1 | ||
Outcome | Overall Survival (OS) |
|
Timepoint | 24 months later |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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