Adjuvant Chemotherapy for Biliary Tract Cancer After Curative Resection

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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 with biliary tract cancer (BTC) after curative resection.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Treatments: Capecitabine; Gemcitabine

Criteria

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