A Phase I Study of Adjuvant Chemotherapy With Gemcitabine Plus Cisplatin in Patients With Biliary Tract Cancer Undergoing Curative Resection Without Major Hepatectomy
20 Years
N/A
Both
Biliary Tract Cancer
Trial Information
A Phase I Study of Adjuvant Chemotherapy With Gemcitabine Plus Cisplatin in Patients With Biliary Tract Cancer Undergoing Curative 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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose
Outcome Description:
To establish the maximum tolerated dose of gemcitabine plus cisplatin in patients with biliary tract cancer undergoing curative resection without major hepatectomy
Outcome Time Frame:
Within 2 courses (every 2 weeks in Level -2 and -1; every 3 weeks in Level 0 and 1)
Safety Issue:
Yes
Principal Investigator
Tetsuo Ajiki, MD, PhD
Investigator Role:
Study Director
Investigator Affiliation:
Kobe University Graduate School of Medicine
Authority:
Japan: Institutional Review Board
Study ID:
KHBO1004
NCT ID:
NCT01297998
Start Date:
January 2011
Completion Date:
June 2013
Related Keywords:
- Biliary Tract Cancer
- Biliary Tract Neoplasms
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