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Adjuvant Chemotherapy for Biliary Tract Cancer After Curative Resection (AdBTC-1)

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ClinicalTrials.gov Identifier: NCT03779035
Recruitment Status : Recruiting
First Posted : December 18, 2018
Last Update Posted : December 18, 2018
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital

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.

Condition or disease Intervention/treatment Phase
Cholangiocarcinoma Gall Bladder Carcinoma Drug: Gemcitabine Drug: Capecitabine Phase 3

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 (GBCA). Because of high rates of disease recurrence and poor survival rates following surgical resection, postoperative treatment have been considered to improve patient survival after resection of BTC. The systematic review showed a beneficial impact of adjuvant treatment in BTC, particularly in patients with involved lymph nodes or resection margins and distal or hilar CCA. However, in regard of the paucity of randomized data, current guidelines recommend inclusion in clinical trials.

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 460 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adjuvant Chemotherapy With Gemcitabine and Capecitabine Compared to Capecitabine for Biliary Tract Cancer After Curative Resection
Estimated Study Start Date : December 15, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2023


Arm Intervention/treatment
Experimental: 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.
Drug: Gemcitabine
1000mg/m2

Drug: Capecitabine
1250mg/m2

Active Comparator: 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.
Drug: Capecitabine
1250mg/m2




Primary Outcome Measures :
  1. Disease free survival (DFS) rate [ Time Frame: at 24 months ]
    DFS


Secondary Outcome Measures :
  1. Overall survival (OS) rate [ Time Frame: at 24 months ]
    OS

  2. Disease free survival (DFS) rate [ Time Frame: at 60 months ]
    DFS

  3. Overall survival (OS) rate [ Time Frame: at 60 months ]
    OS

  4. The rate of patients with hepatic or locoregional recurrence [ Time Frame: 24 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03779035


Contacts
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Contact: Tianqiang Song, PH.D. +86-022-23340123 ext 3090 tjchi@hotmail.com

Locations
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China, Tianjin
Tianjin Medical University Cancer Insititute and Hospital Recruiting
Tianjin, Tianjin, China, 300060
Contact: Tianqiang Song, PH.D.       tjchi@hotmail.com   
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital

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Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT03779035     History of Changes
Other Study ID Numbers: EK2017144
First Posted: December 18, 2018    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Tianjin Medical University Cancer Institute and Hospital:
adjuvant chemotherapy
cholangiocarcinoma
invasive gall bladder carcinoma
overall survival
disease free survival
Gemcitabine
Capecitabine

Additional relevant MeSH terms:
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Cholangiocarcinoma
Biliary Tract Neoplasms
Urinary Bladder Neoplasms
Gallbladder Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Urologic Neoplasms
Urogenital Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Gallbladder Diseases
Gemcitabine
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs