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Trial record 14 of 146 for:    cholangiocarcinoma | Recruiting, Not yet recruiting, Available Studies

Oxaliplatin+Gemcitabine vs Capecitabine as Adjuvant Therapy for Intrahepatic Cholangiocarcinoma

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ClinicalTrials.gov Identifier: NCT02548195
Recruitment Status : Recruiting
First Posted : September 14, 2015
Last Update Posted : September 14, 2015
Sponsor:
Information provided by (Responsible Party):
Hui-Chuan Sun, Shanghai Zhongshan Hospital

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.

Condition or disease Intervention/treatment Phase
Cholangiocarcinoma Drug: oxaliplatin and gemcitabine Drug: capecitabine Phase 3

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  (Clinical Trial)
Estimated Enrollment : 286 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Oxaliplatin Plus Gemcitabine Versus Capecitabine Alone as Adjuvant Treatment in the Prevention of Recurrence of Intrahepatic Cholangiocarcinoma
Study Start Date : July 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018


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 Name: Xeloda




Primary Outcome Measures :
  1. Recurrence-free survival [ Time Frame: from the date of surgery to the date of tumor recurrence up to 36 months after surgery ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: from the date of surgery to the date of death up to 36 months after surgery ]

Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02548195


Contacts
Contact: Hui-Chuan Sun, MD, PhD +86 21 04041990 ext 610559 sun.huichuan@zs-hospital.sh.cn
Contact: Mei-Ling Li livercongress@zs-hospital.sh.cn

Locations
China, Shanghai
Zhongshan Hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: Mei-Ling Li    +86 21 64041990    livercongress@zs-hospital.sh.cn   
Principal Investigator: Hui-Chuan Sun         
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
Study Director: Jinpei Huang Shanghai Zhongshan Hospital

Publications of Results:

Other Publications:
Responsible Party: Hui-Chuan Sun, Vice Director of the Department of Liver Surgery, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT02548195     History of Changes
Other Study ID Numbers: gemoxicc
First Posted: September 14, 2015    Key Record Dates
Last Update Posted: September 14, 2015
Last Verified: September 2015

Keywords provided by Hui-Chuan Sun, Shanghai Zhongshan Hospital:
GEMOX
intrahepatic cholangiocarcinoma
adjuvant therapy
oxaliplatin
gemcitabine
capecitabine
curative surgery

Additional relevant MeSH terms:
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs