Adjuvant Chemotherapy for Biliary Tract Cancer After Curative Resection

NCT03779035 | Unknown Phase 3

• 1 other identifier: EK2017144
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

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 with biliary tract cancer (BTC) after curative resection.

Conditions

Cholangiocarcinoma; Gall Bladder Carcinoma

Keywords

adjuvant chemotherapy; cholangiocarcinoma; invasive gall bladder carcinoma; overall survival; disease free survival; Gemcitabine; Capecitabine

Outcome Measures

Primary Outcomes (1)

• Disease free survival (DFS) rate

  DFS

  at 24 months

Secondary Outcomes (4)

• Overall survival (OS) rate

  at 24 months

• Disease free survival (DFS) rate

  at 60 months

• Overall survival (OS) rate

  at 60 months

• The rate of patients with hepatic or locoregional recurrence

  24 months

Study Arms (2)

Gemcitabine plus Capecitabine

EXPERIMENTAL

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.

Drug: Gemcitabine; Drug: Capecitabine

Capecitabine

ACTIVE COMPARATOR

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.

Drug: Capecitabine

Interventions

Gemcitabine DRUG

1000mg/m2

Gemcitabine plus Capecitabine

Capecitabine DRUG

1250mg/m2

Capecitabine; Gemcitabine plus Capecitabine

Eligibility Criteria

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Insititute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma; Gallbladder Neoplasms

Interventions

Gemcitabine; Capecitabine

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Biliary Tract Diseases; Digestive System Diseases; Gallbladder 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

Tianqiang Song, PH.D.

CONTACT

+86-022-23340123; tjchi@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: December 19, 2018
• Study Start: December 15, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2023
• Last Updated: December 19, 2018

Record last verified: 2018-12

Locations

CN (1)