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

Kansai Hepatobiliary Oncology Group

Status and phase: Completed; Phase 2

Conditions: Biliary Tract Cancer

Treatments: Drug: S-1; Drug: Gemcitabine

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01815307

KHBO1208

UMIN000009945 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Gemcitabine group

Experimental group

Description:

1000mg/m2, day 1 every 2 weeks

Treatment:

Drug: Gemcitabine

S-1 group

Experimental group

Description:

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

Treatment:

Drug: S-1