Prognosis of Resection and Radiotherapy in the Treatment of Intrahepatic Cholangiocarcinoma Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Eastern Hepatobiliary Surgery Hospital
Sponsor:
Information provided by (Responsible Party):
ShenFeng, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier:
NCT01914289
First received: July 31, 2013
Last updated: August 1, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to confirm that prognosis of Intrahepatic Cholangiocarcinoma (ICC) with resection and radiotherapy ,to find which is safe and effective treatment.


Condition Intervention
Intrahepatic Cholangiocarcinoma
Procedure: Resection
Radiation: Radiotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Resection and Radiotherapy in the Prognosis of Intrahepatic Cholangiocarcinoma Patients

Further study details as provided by Eastern Hepatobiliary Surgery Hospital:

Primary Outcome Measures:
  • the overall survival rate of each group [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2011
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Resection
To observe prognosis of resection of icc
Procedure: Resection Radiation: Radiotherapy
Active Comparator: Radiotherapy
To observe the prognosis of radiotherapy treatment of icc
Procedure: Resection Radiation: Radiotherapy

Detailed Description:

Intrahepatic Cholangiocarcinoma (ICC), the second most common primary liver cancer and constitutes 10% of primary liver malignancies.

Current therapies for the treatment of ICC are ineffective and the role of liver transplantation is not well defined.

This study reviews our experience with this tumor and looks for preoperative and pathologic indices that may help determine long term prognosis

  Eligibility

Ages Eligible for Study:   17 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients > 17 years and <=60 years of age. confirmed case (patients with ICC) Tumors can be radical removed and resection volume was ≤50%. Criteria of liver function: Child A level, serum bilirubin ≤ 1.5 times the upper limit of normal value,alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value.

No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal. Hbg ≥ 90g/L, WBC ≥ 3.000 cells/mm³,platelets ≥ 80.000 cells/mm³.

Karnofsky Performance Score performance over 60. Patients who can understand this trial and have signed information consent.

Exclusion Criteria:

  • Patients who have undergone previous treatment by Resection or Radiotherapy. Patients with apparent cardiac, pulmonary, cerebronic and renal dysfunction, which may affect the treatment of liver cancer.

Patients with other diseases which may affect the treatment mentioned here. Patients with medical history of other malignant tumors. Subjects participating in other clinical trials. Extrahepatic metastasis, portal vein or other major vascular involvement. liver function: Child B C.

Patients would not sign the consent to the trial.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01914289

Contacts
Contact: Li Aijun, MD 86-21-81875531 ajli62@gmail.com
Contact: Yuan Hang 86-21-81875531 yuanhang8106@163.com

Locations
China, Shanghai
Eastern Hepatobiliary Surgery Hospital Recruiting
Shanghai, Shanghai, China, 200438
Contact: Li Aijun, MD    86-21-81875531    ajli62@gmail.com   
Contact: Yuan Hang, doctor    86-21-81875531    yuanhang8106@163.com   
Sponsors and Collaborators
Eastern Hepatobiliary Surgery Hospital
Investigators
Study Chair: Li Aijun, MD Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
  More Information

No publications provided

Responsible Party: ShenFeng, director of department of special treatment, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier: NCT01914289     History of Changes
Other Study ID Numbers: EHBH-RCT-2013-002-02
Study First Received: July 31, 2013
Last Updated: August 1, 2013
Health Authority: China: Ministry of Health

Keywords provided by Eastern Hepatobiliary Surgery Hospital:
Intrahepatic Cholangiocarcinoma
Prognosis
Resection
Radiotherapy

Additional relevant MeSH terms:
Cholangiocarcinoma
Liver Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on July 24, 2014