Gemcitabine+ Capecitabine Vs Capecitabine in Curatively Resected Biliary Tract Cancer

NCT04401709 | Unknown Phase 3

• 1 other identifier: 2020-01-101
• Study Type: interventional
• Target: 490
• Locations: 1 country
• Sites: 1

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

Conditions

Biliary Tract Cancer

Outcome Measures

Primary Outcomes (1)

• Two-year disease free survival (DFS)

  24 months later

Secondary Outcomes (1)

• Overall Survival (OS)

  24 months later

Study Arms (2)

Gemcitabine/Capecitabine

EXPERIMENTAL

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

Drug: Gemcitabine/Capecitabine

Capecitabine

ACTIVE COMPARATOR

capecitabine 2,500 mg/m2 D1-14

Drug: Capecitabine

Interventions

Gemcitabine/Capecitabine DRUG

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

Gemcitabine/Capecitabine

Capecitabine DRUG

total 8 cycles Capecitabine 1,250 mg / m2 PO twice daily 1 \~ 14 days for 3 weeks

Capecitabine

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Gemcitabine; Capecitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

JoonOh Park, doctor

CONTACT

82-2-3410-3459; joonoh.park@samsung.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 26, 2020
• Study Start: April 1, 2021
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: June 15, 2022

Record last verified: 2022-06

Locations

KR (1)