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

NCT ID: NCT01297998

Last Updated: 2017-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-06-30

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.

Conditions

Biliary Tract Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

gemcitabine , cisplatin

Group Type: EXPERIMENTAL

gemcitabine , cisplatin

Intervention Type: DRUG

Dose of gemcitabine and cisplatin and treatment schedule

Interventions

gemcitabine , cisplatin

Dose of gemcitabine and cisplatin and treatment schedule

Intervention Type: DRUG

Other Intervention Names

Gemcitabine;gemzer,Cisplatin;Cispulan

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kansai Hepatobiliary Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tetsuo Ajiki, MD, PhD

Role: STUDY_DIRECTOR

Kobe University Graduate School of Medicine

Locations

Kobe University Graduate School of Medicine

Kobe, , Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 24614947 (View on PubMed)

Other Identifiers

UMIN000004622

Identifier Type: REGISTRY

Identifier Source: secondary_id

KHBO1004

Identifier Type: -

Identifier Source: org_study_id