COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

A Phase I Study of Adjuvant Chemotherapy With GC in Biliary Tract Cancer Undergoing Resection Without Major Hepatectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01297998
Recruitment Status : Completed
First Posted : February 17, 2011
Last Update Posted : November 17, 2017
Information provided by (Responsible Party):
Kansai Hepatobiliary Oncology Group

Brief Summary:
To decide maximum tolerated dose and recommended dose of treatment using gemcitabine plus cisplatin combination therapy in patients with biliary tract cancer undergoing resection without major hepatectomy.

Condition or disease Intervention/treatment Phase
Biliary Tract Cancer Drug: gemcitabine , cisplatin Phase 1

Detailed Description:

Surgery currently remains the only potentially curative treatment for biliary tract cancer (BTC), and most patients develop recurrence. Therefore, effective adjuvant chemotherapy is required to increase the curability of surgery and to prolong the survival in these patients. However, to date, no standard adjuvant chemotherapy has been established, and a guideline for BTC treatment recommends that trials of adjuvant chemotherapy be carried out.

Based on results from clinical studies in unresectable BTC, gemcitabine, platinum agent, fluoropyrimidine are considered to have activity against BTC. These agents are expected to be effective in the postoperative adjuvant therapy for BTC, Thus, randomized controlled trials with gemcitabine are ongoing, and the results are expected. Recently, in the ABC-02 study, the first prospective multicenter phase III study in patients with unresectable BTC, gemcitabine/cisplatin combination chemotherapy was compared with gemcitabine monotherapy and showed that the combination therapy significantly prolonged MST (from 8.1 to 11.7 months; P < 0.001). Gemcitabine/cisplatin combination therapy is now considered to be the standard regimen for unresectable BTC, and we expect this regimen to be effective for postoperative adjuvant therapy.

Though hepatectomy is frequently performed in surgery for BTC, it is unclear that the effect of anticancer agent is affected by hepatectomy. Because gemcitabine is metabolized by cytidine deaminase primarily in the liver, it considered to have decreased the metabolic ability of gemcitabine after hepatectomy. Some clinical studies demonstrated that patient with hepatectomy could not tolerate the standard dose and schedule of gemcitabine. In the adjuvant chemotherapy with gemcitabine, it is necessary to examine separately whether hepatectomy was undergone or not.

In this study, we aimed to assess the safety and efficacy of gemcitabine/cisplatin combination chemotherapy in patients with biliary tract cancer undergoing curative resection without hepatectomy.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Adjuvant Chemotherapy With Gemcitabine Plus Cisplatin in Patients With Biliary Tract Cancer Undergoing Curative Resection Without Major Hepatectomy
Study Start Date : January 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : June 2013

Arm Intervention/treatment
Experimental: gemcitabine , cisplatin Drug: gemcitabine , cisplatin
Dose of gemcitabine and cisplatin and treatment schedule
Other Name: Gemcitabine;gemzer,Cisplatin;Cispulan

Primary Outcome Measures :
  1. Maximum tolerated dose [ Time Frame: Within 2 courses (every 2 weeks in Level -2 and -1; every 3 weeks in Level 0 and 1) ]
    To establish the maximum tolerated dose of gemcitabine plus cisplatin in patients with biliary tract cancer undergoing curative resection without major hepatectomy

Secondary Outcome Measures :
  1. Number of Participants with dose limiting toxicity [ Time Frame: At the end of adjuvant chemotherapy (6 months) ]

    Dose limiting toxicity is defined as follows

    1. Grade 4 neutropenia, thrombocytopenia
    2. Grade 3 or 4 febrile neutropenia
    3. Grade 3 or 4 non-hematological adverse events unless unresponsive to treatment
    4. Any adverse events resulting in interruption of dosing on day 8 in both the two courses
    5. Any adverse events resulting in dose modification or delay of longer than 2 week

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Biliary tract cancer (BTC) with more than stage IB
  2. BTC undergoing R0 or R1 resection without major hepatectomy
  3. Older than 20 years old
  4. PS0 or 1
  5. No treatment other than surgery
  6. No dysfunction of main organs
  7. Possible oral intake
  8. Treatment start; after 4 weeks and within 12 weeks after surgery
  9. Obtained written informed consent

Exclusion Criteria:

  1. Patients with resection of major hepatectomy
  2. Patients with double cancers
  3. Patients having severe allergy
  4. Patients with severe organ dysfunction
  5. Patients with active infectious disease
  6. Pregnancy
  7. Patients with severe psychological disease
  8. Patients seem inadequate for this study by investigators

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 identifier (NCT number): NCT01297998

Layout table for location information
Kobe University Graduate School of Medicine
Kobe, Japan, 650-0017
Sponsors and Collaborators
Kansai Hepatobiliary Oncology Group
Layout table for investigator information
Study Director: Tetsuo Ajiki, MD, PhD Kobe University Graduate School of Medicine
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Kansai Hepatobiliary Oncology Group Identifier: NCT01297998    
Other Study ID Numbers: KHBO1004
UMIN000004622 ( Registry Identifier: UMIN )
First Posted: February 17, 2011    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: June 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs