Clinical Study of Effectiveness of Radiotherapy Before Surgery in High-risk Relapse Hepatocellular Cancer Patients
Effectiveness of Radiotherapy Before Surgery in Patients With High-risk Relapse Hepatocellular Carcinoma
1 other identifier
interventional
50
1 country
1
Brief Summary
This study aims to evaluate the effectiveness of radiotherapy before surgery in high-risk relapse hepatocellular cancer patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 10, 2015
CompletedFirst Posted
Study publicly available on registry
October 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedOctober 22, 2015
October 1, 2015
1.8 years
October 10, 2015
October 21, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
mortality
5 years
Study Arms (2)
radiation
EXPERIMENTALno radiation
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peking Union Medical Collegelead
- Beijing Hope Runcollaborator
Study Sites (1)
WU FAN
Beijing, China
Related Publications (1)
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.
PMID: 36197682DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
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
- Doctor
Study Record Dates
First Submitted
October 10, 2015
First Posted
October 20, 2015
Study Start
October 1, 2014
Primary Completion
July 1, 2016
Study Completion
July 1, 2017
Last Updated
October 22, 2015
Record last verified: 2015-10