Status:
UNKNOWN
Adjuvant Chemotherapy for Biliary Tract Cancer After Curative Resection
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Conditions:
Cholangiocarcinoma
Gall Bladder Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This prospective, open-Label, comparative, randomized, controlled phase III trial was designed to compare the clinical performance of gemcitabine with capecitabine vs. capecitabine alone for patients ...
Detailed Description
Currently, complete surgical resection represents the only potentially curative treatment option for cholangiocarcinoma (CCA, including intrahepatic, hilar and distal CCA) and gallbladder carcinoma (G...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed biliary tract cancer (including intrahepatic, extrahepatic, hilar cholangiocarcinoma or muscle invasive gallbladder cancer or cancer of the distal bile duct)
- Must have undergone a radical surgical approach which includes liver resection, pancreatic resection, or less commonly both
- Patients with pathological evidence of microscopic involvement of the margins of the excised specimen are eligible as long as resection is macroscopically complete
- Must be able to start treatment within 12 weeks of surgery
- 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
Exclusion
Key Trial Info
Start Date :
December 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
460 Patients enrolled
Trial Details
Trial ID
NCT03779035
Start Date
December 15 2018
End Date
December 31 2023
Last Update
December 19 2018
Active Locations (1)
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1
Tianjin Medical University Cancer Insititute and Hospital
Tianjin, Tianjin Municipality, China, 300060