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

Sponsor
Kansai Hepatobiliary Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT01815307
Collaborator
(none)
70
Enrollment
1
Location
2
Arms
59
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Phase II Study of Gemcitabine Versus S-1 Adjuvant Therapy After Hemihepatectomy for Biliary Tract Cancer
Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
May 1, 2016
Actual Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Gemcitabine group

1000mg/m2, day 1 every 2 weeks

Drug: Gemcitabine
1000mg/m2, day 1 every 2 weeks
Other Names:
  • gemzer

    		•
    Experimental: S-1 group

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

    Drug: S-1
    80mg/m2/day, day 1-28, every 6 weeks
    Other Names:
  • TS-1

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 1 year recurrent free survival rate [One year]

      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

    1. Two-year recurrent free survival rate [Two years]

    2. One-year overall survival rate [One year]

    3. Two-year overall survival rate [Two years]

    4. Completion rate of the protocol treatment [6 months]

    5. Dose intensity of anti-tumor drugs [6 months]

    6. Rate and grade of adverse events or adverse drug reactions [6 months]

    7. Duration of recurrent free survival [an expected average of 2 years]

    8. Duration of overall survival [an expected average of 3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Osaka University, Graduate School of Medicine Osaka Japan 565-0871

    Sponsors and Collaborators

    • Kansai Hepatobiliary Oncology Group

    Investigators

    • Study Director: Hiroaki Nagano, MD, PhD, Osaka University Graduate School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kansai Hepatobiliary Oncology Group
    ClinicalTrials.gov Identifier:
    NCT01815307
    Other Study ID Numbers:
    • KHBO1208
    • UMIN000009945
    First Posted:
    Mar 21, 2013
    Last Update Posted:
    May 16, 2018
    Last Verified:
    Sep 1, 2017
    Additional relevant MeSH terms:
    Biliary Tract Neoplasms
    Gemcitabine

    Study Results

    No Results Posted as of May 16, 2018