Oxaliplatin+Gemcitabine vs Capecitabine as Adjuvant Therapy for Intrahepatic Cholangiocarcinoma

September 11, 2015 updated by: Hui-Chuan Sun, Shanghai Zhongshan Hospital

Oxaliplatin Plus Gemcitabine Versus Capecitabine Alone as Adjuvant Treatment in the Prevention of Recurrence of Intrahepatic Cholangiocarcinoma

To evaluate of adjuvant therapy using oxaliplatin and gemcitabine (GEMOX regimen) versus capecitabine alone chemotherapy in patients who underwent curative surgery for intrahepatic cholangiocarcinoma (ICC) -- a randomized control study.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

chemotherapy: GEMOX vs capecitabine alone; adjuvant settings; primary endpoint: recurrence-free survival (RFS); second endpoint: overall survival after surgery (OS).

Study Type

Interventional

Enrollment (Anticipated)

286

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Zhongshan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ECOG PS≤1;
  • pathologically confirmed adenocarcinoma of bile duct;
  • R1 resection or R0 resection with these risk factors: lymph node metastasis, lymphatic vessel or blood vessel invasion, multiple tumors, tumor size >5 cm, preoperative CA199>200 U/mL.
  • postoperative liver function Child Pugh Class A, leukocyte count>1.5*10^9/L, platelet count>100*10^9/L, serum alanine aminotransferase <1.5*ULN
  • no tumor recurrence or metastasis on baseline examination
  • no history of radiotherapy or intervention therapy

Exclusion Criteria:

  • hepatocellular carcinoma, mixed carcinoma of ICC and HCC, or hilar cholangiocarcinoma
  • distant metastasis
  • prothrombin time >14s
  • severe cardiopulmonary dysfunction
  • severe renal dysfunction
  • bone marrow suppression before the initiation of therapy
  • allergic to fluorouracil, gemcitabine, or platinum
  • gemcitabine was used in combination with radiotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: GEMOX
oxaliplatin and gemcitabine (GEMOX regimen): day 1: oxaliplatin 85 mg/m2, gemcitabine 1000 mg/m2; day 8: gemcitabine 1000 mg/m2; every three weeks for 6-8 cycles in total.
Drug: oxaliplatin and gemcitabine
oxaliplatin and gemcitabine (GEMOX regimen): day 1: oxaliplatin 85 mg/m2, gemcitabine 1000 mg/m2; day 8: gemcitabine 1000 mg/m2 every three weeks for 6-8 cycles in total.
Other Names:
  • oxaliplatin
  • gemcitabine
ACTIVE_COMPARATOR: Capecitabine
capecitabine 1250 mg/m2, twice daily for two weeks plus one week rest for 8 cycles in total.
Drug: capecitabine
capecitabine 1250 mg/m2, twice daily for two weeks plus one week rest for 8 cycles in total.
Other Names:
  • Xeloda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence-free survival
Time Frame: from the date of surgery to the date of tumor recurrence up to 36 months after surgery
from the date of surgery to the date of tumor recurrence up to 36 months after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: from the date of surgery to the date of death up to 36 months after surgery
from the date of surgery to the date of death up to 36 months after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events and severe adverse events
Time Frame: from the date of first dosage to safety follow-up visit (30 days after the last dosage)
All toxicities will be graded by CTCAE v4
from the date of first dosage to safety follow-up visit (30 days after the last dosage)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Investigators

  • Study Director: Jinpei Huang, Shanghai Zhongshan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (ANTICIPATED)

June 1, 2018

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

August 7, 2015

First Submitted That Met QC Criteria

September 11, 2015

First Posted (ESTIMATE)

September 14, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

September 14, 2015

Last Update Submitted That Met QC Criteria

September 11, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • gemoxicc

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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