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

Primary Purpose

Biliary Tract Cancer

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

Gemcitabine

S-1

About this trial

This is an interventional treatment trial for Biliary Tract Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Biliary tract cancer (BTC) (>= Unio Internationalis Contra Cancrum (UICC) Stage IB), adenocarcinoma
R0 or R1 resection
no obvious recurrent lesion
20 years old or more
Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1
The patient underwent no other treatment than surgery for BTC
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
The patient can intake drugs per os.
From 4 to 12 weeks after the surgery
Written informed consent

Exclusion Criteria:

Existence of active double cancer
The patient suffered from severe drug allergy
Sever complications (interstitial pneumonia, heart failure, renal failure, liver failure, ileus, incontrollable diabetes mellitus, and so on)
Any active infections exist.
Pregnancy
Severe mental disorder
Others

Sites / Locations

Osaka University, Graduate School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Gemcitabine group

S-1 group

Arm Description

1000mg/m2, day 1 every 2 weeks

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

Outcomes

Primary Outcome Measures

1 year recurrent free survival rate

Duration: From randomization to evidenced recurrence or death. Rate: Number of patients with evidenced recurrence or death / number of total patients. 1 year recurrent free survival rate: recurrent free survival rate at one-year from the randomization

Secondary Outcome Measures

Two-year recurrent free survival rate

One-year overall survival rate

Two-year overall survival rate

Completion rate of the protocol treatment

Dose intensity of anti-tumor drugs

Rate and grade of adverse events or adverse drug reactions

Duration of recurrent free survival

Duration of overall survival

Full Information

NCT ID

NCT01815307

First Posted

March 5, 2013

Last Updated

May 15, 2018

Sponsor

Kansai Hepatobiliary Oncology Group

1. Study Identification

Unique Protocol Identification Number

NCT01815307

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kansai Hepatobiliary Oncology Group

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Biliary Tract Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gemcitabine group

Arm Type

Experimental

Arm Description

1000mg/m2, day 1 every 2 weeks

Arm Title

S-1 group

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Other Intervention Name(s)

gemzer

Intervention Description

1000mg/m2, day 1 every 2 weeks

Intervention Type

Drug

Intervention Name(s)

S-1

Other Intervention Name(s)

TS-1

Intervention Description

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

Primary Outcome Measure Information:

Title

1 year recurrent free survival rate

Description

Time Frame

One year

Secondary Outcome Measure Information:

Title

Two-year recurrent free survival rate

Time Frame

Two years

Title

One-year overall survival rate

Time Frame

One year

Title

Two-year overall survival rate

Time Frame

Two years

Title

Completion rate of the protocol treatment

Time Frame

6 months

Title

Dose intensity of anti-tumor drugs

Time Frame

6 months

Title

Rate and grade of adverse events or adverse drug reactions

Time Frame

6 months

Title

Duration of recurrent free survival

Time Frame

an expected average of 2 years

Title

Duration of overall survival

Time Frame

an expected average of 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Biliary tract cancer (BTC) (>= Unio Internationalis Contra Cancrum (UICC) Stage IB), adenocarcinoma R0 or R1 resection no obvious recurrent lesion 20 years old or more Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1 The patient underwent no other treatment than surgery for BTC 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 The patient can intake drugs per os. From 4 to 12 weeks after the surgery Written informed consent Exclusion Criteria: Existence of active double cancer The patient suffered from severe drug allergy Sever complications (interstitial pneumonia, heart failure, renal failure, liver failure, ileus, incontrollable diabetes mellitus, and so on) Any active infections exist. Pregnancy Severe mental disorder Others

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hiroaki Nagano, MD, PhD

Organizational Affiliation

Osaka University Graduate School of Medicine

Official's Role

Study Director

Facility Information:

Facility Name

Osaka University, Graduate School of Medicine

City

Osaka

ZIP/Postal Code

565-0871

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

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