Phase II Study of Gemcitabine Versus S-1 Adjuvant Therapy After Hemihepatectomy for Biliary Tract Cancer

NCT ID: NCT01815307

Last Updated: 2018-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2017-12-31

Brief Summary

To compare efficacy and safety of Gemcitabine versus S-1 adjuvant therapy after hemihepatectomy.

Detailed Description

There is no standard adjuvant therapy after liver hemi-hepatectomy due to bile duct cancer, because of high surgical morbidity ratio and high adverse event ratio of adjuvant therapy. For example, our preliminary results showed that regular gemcitabine administration (1000mg/m2, day 1, 8, 15 every 4 weeks) after hemihepatectomy was too toxic and induced severe leukocytopenia and/or thrombocytopenia. Formerly, the investigators planned the study to decide more safety adjuvant protocol (recommend dose: RD) for Gemcitabine or S-1 after hemihepatectomy using Continuous Reassessment Method (CRM) analysis and decided the recommend doses. Note: In the former study, the investigators decided that tolerable ratio of Dose Limiting Toxicity (DLT) would be less than 10%.

Herein, the investigators planned the study to evaluate efficacy (recurrent free survival as primary outcome, and overall-survival as secondary outcome) and safety (as secondary outcome) in our recommended protocols, and to compare the efficacy as randomized control trial.

Conditions

Biliary Tract Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gemcitabine group

1000mg/m2, day 1 every 2 weeks

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

1000mg/m2, day 1 every 2 weeks

S-1 group

80mg/m2/day, day 1-28, every 6 weeks

Group Type: EXPERIMENTAL

S-1

Intervention Type: DRUG

80mg/m2/day, day 1-28, every 6 weeks

Interventions

Gemcitabine

1000mg/m2, day 1 every 2 weeks

Intervention Type: DRUG

S-1

80mg/m2/day, day 1-28, every 6 weeks

Intervention Type: DRUG

Other Intervention Names

gemzer; TS-1

Eligibility Criteria

Inclusion Criteria

1. Biliary tract cancer (BTC) (>= Unio Internationalis Contra Cancrum (UICC) Stage IB), adenocarcinoma

2. R0 or R1 resection

3. no obvious recurrent lesion

4. 20 years old or more

5. Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1

6. The patient underwent no other treatment than surgery for BTC

7. Neutrophil must be over 1500/μl, Hemoglobin must be over 9.0g/dL, platelet must be over 100,000/μl, Aspartate transaminase (AST) and Alanine aminotransferase (ALT) must be less than 150 IU/L, total bilirubin must be less than 1.5 mg/dL, Creatinine must be less than 1.2 mg/dl, and Creatinine clearance must be over 60 mL/min

8. The patient can intake drugs per os.

9. From 4 to 12 weeks after the surgery

10. Written informed consent

Exclusion Criteria

1. Existence of active double cancer

2. The patient suffered from severe drug allergy

3. Sever complications (interstitial pneumonia, heart failure, renal failure, liver failure, ileus, incontrollable diabetes mellitus, and so on)

4. Any active infections exist.

5. Pregnancy

6. Severe mental disorder

7. Others

• 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

Hiroaki Nagano, MD, PhD

Role: STUDY_DIRECTOR

Osaka University Graduate School of Medicine

Locations

Osaka University, Graduate School of Medicine

Osaka, , Japan

Countries

Japan

Other Identifiers

UMIN000009945

Identifier Type: REGISTRY

Identifier Source: secondary_id

KHBO1208

Identifier Type: -

Identifier Source: org_study_id