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Oxaliplatin+Gemcitabine vs Capecitabine as Adjuvant Therapy for Intrahepatic Cholangiocarcinoma

Primary Purpose

Cholangiocarcinoma

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
oxaliplatin and gemcitabine
capecitabine
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cholangiocarcinoma focused on measuring GEMOX, intrahepatic cholangiocarcinoma, adjuvant therapy, oxaliplatin, gemcitabine, capecitabine, curative surgery

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zhongshan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GEMOX

Capecitabine

Arm Description

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.

capecitabine 1250 mg/m2, twice daily for two weeks plus one week rest for 8 cycles in total.

Outcomes

Primary Outcome Measures

Recurrence-free survival

Secondary Outcome Measures

Overall survival

Full Information

First Posted
August 7, 2015
Last Updated
September 11, 2015
Sponsor
Shanghai Zhongshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02548195
Brief Title
Oxaliplatin+Gemcitabine vs Capecitabine as Adjuvant Therapy for Intrahepatic Cholangiocarcinoma
Official Title
Oxaliplatin Plus Gemcitabine Versus Capecitabine Alone as Adjuvant Treatment in the Prevention of Recurrence of Intrahepatic Cholangiocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Zhongshan Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangiocarcinoma
Keywords
GEMOX, intrahepatic cholangiocarcinoma, adjuvant therapy, oxaliplatin, gemcitabine, capecitabine, curative surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
286 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GEMOX
Arm Type
Experimental
Arm Description
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.
Arm Title
Capecitabine
Arm Type
Active Comparator
Arm Description
capecitabine 1250 mg/m2, twice daily for two weeks plus one week rest for 8 cycles in total.
Intervention Type
Drug
Intervention Name(s)
oxaliplatin and gemcitabine
Other Intervention Name(s)
oxaliplatin, gemcitabine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
capecitabine 1250 mg/m2, twice daily for two weeks plus one week rest for 8 cycles in total.
Primary Outcome Measure Information:
Title
Recurrence-free survival
Time Frame
from the date of surgery to the date of tumor recurrence up to 36 months after surgery
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
from the date of surgery to the date of death up to 36 months after surgery
Other Pre-specified Outcome Measures:
Title
Number of participants with adverse events and severe adverse events
Description
All toxicities will be graded by CTCAE v4
Time Frame
from the date of first dosage to safety follow-up visit (30 days after the last dosage)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui-Chuan Sun, MD, PhD
Phone
+86 21 04041990
Ext
610559
Email
sun.huichuan@zs-hospital.sh.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Mei-Ling Li
Email
livercongress@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinpei Huang
Organizational Affiliation
Shanghai Zhongshan Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mei-Ling Li
Phone
+86 21 64041990
Email
livercongress@zs-hospital.sh.cn
First Name & Middle Initial & Last Name & Degree
Hui-Chuan Sun

12. IPD Sharing Statement

Citations:
PubMed Identifier
22237781
Citation
Siegel R, Naishadham D, Jemal A. Cancer statistics, 2012. CA Cancer J Clin. 2012 Jan-Feb;62(1):10-29. doi: 10.3322/caac.20138. Epub 2012 Jan 4.
Results Reference
background
PubMed Identifier
20165987
Citation
Cho SY, Park SJ, Kim SH, Han SS, Kim YK, Lee KW, Lee SA, Hong EK, Lee WJ, Woo SM. Survival analysis of intrahepatic cholangiocarcinoma after resection. Ann Surg Oncol. 2010 Jul;17(7):1823-30. doi: 10.1245/s10434-010-0938-y. Epub 2010 Feb 18.
Results Reference
result
PubMed Identifier
25456367
Citation
Schmoll HJ, Twelves C, Sun W, O'Connell MJ, Cartwright T, McKenna E, Saif M, Lee S, Yothers G, Haller D. Effect of adjuvant capecitabine or fluorouracil, with or without oxaliplatin, on survival outcomes in stage III colon cancer and the effect of oxaliplatin on post-relapse survival: a pooled analysis of individual patient data from four randomised controlled trials. Lancet Oncol. 2014 Dec;15(13):1481-1492. doi: 10.1016/S1470-2045(14)70486-3. Epub 2014 Nov 12.
Results Reference
result
PubMed Identifier
8708722
Citation
Patt YZ, Jones DV Jr, Hoque A, Lozano R, Markowitz A, Raijman I, Lynch P, Charnsangavej C. Phase II trial of intravenous flourouracil and subcutaneous interferon alfa-2b for biliary tract cancer. J Clin Oncol. 1996 Aug;14(8):2311-5. doi: 10.1200/JCO.1996.14.8.2311.
Results Reference
result
PubMed Identifier
15691639
Citation
Ducreux M, Van Cutsem E, Van Laethem JL, Gress TM, Jeziorski K, Rougier P, Wagener T, Anak O, Baron B, Nordlinger B; EORTC Gastro Intestinal Tract Cancer Group. A randomised phase II trial of weekly high-dose 5-fluorouracil with and without folinic acid and cisplatin in patients with advanced biliary tract carcinoma: results of the 40955 EORTC trial. Eur J Cancer. 2005 Feb;41(3):398-403. doi: 10.1016/j.ejca.2004.10.026.
Results Reference
result
PubMed Identifier
20375404
Citation
Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. doi: 10.1056/NEJMoa0908721.
Results Reference
result

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Oxaliplatin+Gemcitabine vs Capecitabine as Adjuvant Therapy for Intrahepatic Cholangiocarcinoma

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