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

NCT01914289 | Unknown DMC

• 1 other identifier: EHBH-RCT-2013-002-02
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intrahepatic Cholangiocarcinoma

Keywords

Intrahepatic Cholangiocarcinoma; Prognosis; Resection; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• the overall survival rate of each group

  3 years

Study Arms (2)

Resection

EXPERIMENTAL

To observe prognosis of resection of icc

Procedure: Resection; Radiation: Radiotherapy

Radiotherapy

ACTIVE COMPARATOR

To observe the prognosis of radiotherapy treatment of icc

Procedure: Resection; Radiation: Radiotherapy

Interventions

Resection PROCEDURE

Radiotherapy; Resection

Radiotherapy RADIATION

Radiotherapy; Resection

Eligibility Criteria

• Age: 17 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eastern Hepatobiliary Surgery Hospital: lead

Study Sites (1)

Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, 200438, China

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Li Aijun, MD

  Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

  STUDY CHAIR

Central Study Contacts

Li Aijun, MD

CONTACT

86-21-81875531; ajli62@gmail.com

Yuan Hang

CONTACT

86-21-81875531; yuanhang8106@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of department of special treatment

Study Record Dates

• First Submitted: July 31, 2013
• First Posted: August 2, 2013
• Study Start: January 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2016
• Last Updated: March 31, 2016

Record last verified: 2016-03

Locations

CN (1)