Adjuvant Chemotherapy for Biliary Tract Cancer After Curative Resection
NCT ID: NCT03779035
Last Updated: 2018-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
460 participants
INTERVENTIONAL
2018-12-15
2023-12-31
Brief Summary
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Detailed Description
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Previously, the data of the BILCAP trial showed an improvement in median overall survival for capecitabine compared to observation alone for BTC, indicating capecitabine as the new standard postoperative treatment after curative resection of BTC.
Previous phase II studies for advanced BTC showed superiority of the combination gemcitabine/ capecitabine regimen vs. the capecitabine monotherapy, the median OS was 12.7-14 vs. 7.9 months.
Based on these data, this AdBTC trial will was designed to compare the clinical performance of gemcitabine with capecitabine vs. capecitabine alone for patients with biliary tract cancer (BTC) after curative resection, aiming for superiority of the combination regimen vs. the oral monotherapy. This will be based on the BILCAP protocol, applying the similar dosing, assessments and dose modifications.
The primary endpoint is DFS and secondary endpoints include recurrence free survival, OS, safety and tolerability of adjuvant CTx, quality of life, and patterns of disease recurrence.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Capecitabine
Capecitabine (1250 mg per square meter) twice a day on days 1-14. Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.
Capecitabine
1250mg/m2
Gemcitabine plus Capecitabine
Gemcitabine (1000 mg per square meter) on days 1 and 8 Capecitabine (1250 mg per square meter) twice a day on days 1-14. Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.
Gemcitabine
1000mg/m2
Capecitabine
1250mg/m2
Interventions
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Gemcitabine
1000mg/m2
Capecitabine
1250mg/m2
Eligibility Criteria
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Inclusion Criteria
* No pancreatic or periampullary cancer
* No mucosal gallbladder cancer
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Urea \< 1.5 times upper limit of normal (ULN)
* Creatinine \< 1.5 times ULN
* Glomerular filtration rate ≥ 60 mL/min (if \< 60 mL/min, adequate renal function for capecitabine must be confirmed by isotope EDTA)
* Hemoglobin ≥ 10 g/dL
* WBC ≥ 3,000/mm³
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Bilirubin ≤ 3 times ULN
* ALT and AST ≤ 5 times ULN
* Adequate surgical biliary drainage with no evidence of infection
* Not pregnant or nursing
* Negative pregnancy test for women of childbearing age and childbearing potential
* Fertile patients must use effective contraception during study treatment and for at least 3 months after study treatment has ended
* Must provide written informed consent
* No history of other malignant diseases within the past 5 years
* No serious coexisting medical condition likely to interfere with protocol treatment, including a potential serious infection
* No evidence of significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial
* No psychological, familial, sociological, or geographical factors considered likely to preclude study compliance
* No other serious uncontrolled medical conditions
* No unresolved biliary tree obstruction
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Completely recovered from prior surgery
* No use of other investigational agents within 28 days prior to and during study treatment
* No prior chemotherapy or radiotherapy for biliary tract cancer
* No other concurrent anticancer chemotherapy, radiotherapy, or investigational agent
18 Years
ALL
No
Sponsors
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Tianjin Medical University Cancer Institute and Hospital
OTHER
Responsible Party
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Locations
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Tianjin Medical University Cancer Insititute and Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Tianqiang Song, PH.D.
Role: primary
Other Identifiers
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EK2017144
Identifier Type: -
Identifier Source: org_study_id