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

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Brief Title

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

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

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.
    

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.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Maximum tolerated dose

Secondary Outcome

 Number of Participants with dose limiting toxicity

Condition

Biliary Tract Cancer

Intervention

gemcitabine , cisplatin

Study Arms / Comparison Groups

 gemcitabine , cisplatin
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

24

Start Date

January 2011

Completion Date

June 2013

Primary Completion Date

December 2012

Eligibility Criteria

        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
      

Gender

All

Ages

20 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Tetsuo Ajiki, MD, PhD, , 

Location Countries

Japan

Location Countries

Japan

Administrative Informations


NCT ID

NCT01297998

Organization ID

KHBO1004

Secondary IDs

UMIN000004622

Responsible Party

Sponsor

Study Sponsor

Kansai Hepatobiliary Oncology Group


Study Sponsor

Tetsuo Ajiki, MD, PhD, Study Director, Kobe University Graduate School of Medicine


Verification Date

June 2014