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

This study has been completed.
Information provided by (Responsible Party):
Kansai Hepatobiliary Oncology Group Identifier:
First received: February 7, 2011
Last updated: June 29, 2014
Last verified: June 2014

February 7, 2011
June 29, 2014
January 2011
December 2012   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01297998 on Archive Site
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
Same as current
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A Phase I Study of Adjuvant Chemotherapy With GC in Biliary Tract Cancer Undergoing Resection Without Major Hepatectomy
A Phase I Study of Adjuvant Chemotherapy With Gemcitabine Plus Cisplatin in Patients With Biliary Tract Cancer Undergoing Curative Resection Without Major Hepatectomy
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.

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.

Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Biliary Tract Cancer
Drug: gemcitabine , cisplatin
Dose of gemcitabine and cisplatin and treatment schedule
Other Name: Gemcitabine;gemzer,Cisplatin;Cispulan
Experimental: gemcitabine , cisplatin
Intervention: Drug: gemcitabine , cisplatin
Toyoda M, Ajiki T, Fujiwara Y, Nagano H, Kobayashi S, Sakai D, Hatano E, Kanai M, Nakamori S, Miyamoto A, Tsuji A, Kaihara S, Ikoma H, Takemura S, Toyokawa H, Terajima H, Morita S, Ioka T. Phase I study of adjuvant chemotherapy with gemcitabine plus cisplatin in patients with biliary tract cancer undergoing curative resection without major hepatectomy (KHBO1004). Cancer Chemother Pharmacol. 2014 Jun;73(6):1295-301. doi: 10.1007/s00280-014-2431-y. Epub 2014 Mar 11.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2013
December 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
UMIN000004622 ( Registry Identifier: UMIN )
Not Provided
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Kansai Hepatobiliary Oncology Group
Kansai Hepatobiliary Oncology Group
Not Provided
Study Director: Tetsuo Ajiki, MD, PhD Kobe University Graduate School of Medicine
Kansai Hepatobiliary Oncology Group
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP