Study of Postoperative 3D-CRT/IMRT in Hepatocellular Carcinoma
Phase 2 Study of Postoperative Three-dimensional Conformal Radiation Therapy/Intensive Modulated Radiation Therapy in Hepatocellular Carcinoma: a Single Center Prospective Study
1 other identifier
interventional
76
1 country
1
Brief Summary
Hepatectomy is difficult when the tumor is adjacent to the big vessels of the liver and some patients can not receive radical resection. Such patients have high risk of recurrence. Tumor resection and postoperative radiation is an option for such patients to achieve radical treatment and radiation may reduce local recurrence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 12, 2011
CompletedFirst Posted
Study publicly available on registry
October 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedJuly 5, 2017
July 1, 2017
9 years
October 12, 2011
July 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall survival
the rate of overall survival for 3 year
3 year
Secondary Outcomes (3)
local recurrence free survival
3 years
disease free survival
3 years
Number of Participants with Adverse Events
3 years
Study Arms (1)
hepatectomy plus radiotherapy
EXPERIMENTALInterventions
IMRT or 3DCRT, 50-60Gy to the tumor bed
Eligibility Criteria
You may qualify if:
- written informed consent provided
- \~75 years old
- patients with histopathological proved hepatocellular carcinoma received hepatectomy and had at least one risk factor of recurrence
- without any lymph node or distant metastasis (any T N0M0)
- liver function: Child-Pugh A or B
- Performance status: Karnofsky (KPS)≥70 or world health organization(WHO) score 0,1
- life expectation\>6 months
- no dysfunction of major organs
- no prior radiotherapy
- negative for human immunodeficiency virus syndrome (HIV)
- Considerable to computed tomography(CT) simulation and 3D-CRT or IMRT
You may not qualify if:
- malignant tumors of other sits
- combining severe diseases, such as acute myocardial infarction(AMI), arrhythmias, infection
- surgery performed in other hospitals without details
- pregnant woman or woman need to breast feed or woman with positive chorionic gonadotrophin (HCG)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Related Publications (1)
Chen B, Wu JX, Cheng SH, Wang LM, Rong WQ, Wu F, Wang SL, Jin J, Liu YP, Song YW, Ren H, Fang H, Tang Y, Li N, Li YX, Wang WH. Phase 2 Study of Adjuvant Radiotherapy Following Narrow-Margin Hepatectomy in Patients With HCC. Hepatology. 2021 Nov;74(5):2595-2604. doi: 10.1002/hep.31993. Epub 2021 Sep 16.
PMID: 34097307DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 12, 2011
First Posted
October 20, 2011
Study Start
January 1, 2008
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
July 5, 2017
Record last verified: 2017-07