Back to resultsClinical Study of Effectiveness of Radiotherapy Before Surgery in High-risk Relapse Hepatocellular Cancer Patients
Primary Purpose
Carcinoma, Hepatocellular
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring Radiotherapy, General Surgery
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of HCC
- In high risk of recurrence of HCC but still can endure palliative resection
- KPS scores are >90
- With Child-Pugh Class A liver funcion, serum bilirubin< 1.5*normal maxism; ALT and AST< 1.5*normal maxism; normal creatinine and urea nitrogen; WBC>4×109/L, Hb>110g/L, PLT>90X109/L.
- Have signed informed consent
Exclusion Criteria:
- HCC cannot be operated
- With Child-Pugh Class B/C
- Have other organ cancer, excluding curative non-melanotic skin cancer and carcinoma in situ of cervix
- Have other severe disease
- With active hepatitis
- Have accepted local radiation therapy in other hospitals
- KPS scores≤70
- Tumor edges cannot be defined
- Have severe cirrhosis complication
- Intensity modulated radiation therapy cannot reach required dose
- Cannot cooperate
- Lactant or pregnant
- Cannnot be informed
Sites / Locations
- WU FANRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
radiation
no radiation
Arm Description
Outcomes
Primary Outcome Measures
mortality
Secondary Outcome Measures
Full Information
NCT ID
NCT02580929
First Posted
October 10, 2015
Last Updated
October 21, 2015
Sponsor
Peking Union Medical College
Collaborators
Beijing Hope Run
1. Study Identification
Unique Protocol Identification Number
NCT02580929
Brief Title
Clinical Study of Effectiveness of Radiotherapy Before Surgery in High-risk Relapse Hepatocellular Cancer Patients
Official Title
Effectiveness of Radiotherapy Before Surgery in Patients With High-risk Relapse Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
July 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College
Collaborators
Beijing Hope Run
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aims to evaluate the effectiveness of radiotherapy before surgery in high-risk relapse hepatocellular cancer patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular
Keywords
Radiotherapy, General Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
radiation
Arm Type
Experimental
Arm Title
no radiation
Arm Type
No Intervention
Intervention Type
Radiation
Intervention Name(s)
radiotherapy
Intervention Description
radiotherapy before surgery
Primary Outcome Measure Information:
Title
mortality
Time Frame
5 years
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:
Clinical diagnosis of HCC
In high risk of recurrence of HCC but still can endure palliative resection
KPS scores are >90
With Child-Pugh Class A liver funcion, serum bilirubin< 1.5*normal maxism; ALT and AST< 1.5*normal maxism; normal creatinine and urea nitrogen; WBC>4×109/L, Hb>110g/L, PLT>90X109/L.
Have signed informed consent
Exclusion Criteria:
HCC cannot be operated
With Child-Pugh Class B/C
Have other organ cancer, excluding curative non-melanotic skin cancer and carcinoma in situ of cervix
Have other severe disease
With active hepatitis
Have accepted local radiation therapy in other hospitals
KPS scores≤70
Tumor edges cannot be defined
Have severe cirrhosis complication
Intensity modulated radiation therapy cannot reach required dose
Cannot cooperate
Lactant or pregnant
Cannnot be informed
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
FAN WU
Email
wufan1011@126.com
Facility Information:
Facility Name
WU FAN
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
WU FAN
Email
wufan1011@126.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
36197682
Citation
Wu F, Chen B, Dong D, Rong W, Wang H, Wang L, Wang S, Jin J, Song Y, Liu Y, Fang H, Tang Y, Li N, Zhu X, Li Y, Wang W, Wu J. Phase 2 Evaluation of Neoadjuvant Intensity-Modulated Radiotherapy in Centrally Located Hepatocellular Carcinoma: A Nonrandomized Controlled Trial. JAMA Surg. 2022 Dec 1;157(12):1089-1096. doi: 10.1001/jamasurg.2022.4702. Erratum In: JAMA Surg. 2022 Dec 1;157(12):1171.
Results Reference
derived
Learn more about this trial
Clinical Study of Effectiveness of Radiotherapy Before Surgery in High-risk Relapse Hepatocellular Cancer Patients
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