Hepatocellular CancerNCT01456156
Study of Postoperative 3D-CRT/IMRT in Hepatocellular Carcinoma
A study testing postoperative radiotherapy in people with Hepatocellular Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Cancer
- What is being tested?
- postoperative radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- Jan 2008to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- written informed consent provided
- 18~75 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
Show all 11Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
About this study
Official title: Phase 2 Study of Postoperative Three-dimensional Conformal Radiation Therapy/Intensive Modulated Radiation Therapy in Hepatocellular Carcinoma: a Single Center Prospective Study
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.
Read the detailed description
Patients with risk factors of recurrence receive postoperative radiotherapy using intensive modulated radiation therapy (IMRT) or three-dimensional conformal radiation therapy (3DCRT). The clinical target volume includes tumor bed. The dose will be 50-60Gy/25-30f. Overall survival, local-recurrence free survival, disease free survival and toxicity need be observed.
- Conditions
- Hepatocellular Cancer
- Being tested
- postoperative radiotherapy
- Keywords
- hepatocellular carcinoma, postoperative radiotherapy
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
postoperative radiotherapyRadiation
Also called adjuvant radiotherapy
IMRT or 3DCRT, 50-60Gy to the tumor bed
| Study group | Role | What they receive |
|---|---|---|
| hepatectomy plus radiotherapy | Experimental | Not described Receives: Radiation: postoperative radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
the rate of overall survival for 3 year
Measured: 3 year
Secondary outcomes (3)
local recurrence free survival
the rate of local recurrence free survival for 3 years
Measured: 3 years
disease free survival
the rate of disease free survival for 3 years
Measured: 3 years
Number of Participants with Adverse Events
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startJan 2008
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tao Zhang, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01456156
- Sponsor's protocol ID
- CH-GI-019
- Status last verified
- Jul 2017
- First submitted
- 12 Oct 2011
- Last updated
- 5 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34097307
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Postoperative Three-dimensional Conformal Radiation Therapy/Intensive Modulated Radiation Therapy in Hepatocellular Carcinoma: a Single Center Prospective Study
- ClinicalTrials.gov ID
- NCT01456156
- Acronym / sponsor ID
- CH-GI-019
- Conditions
- Hepatocellular Cancer
- Keywords
- hepatocellular carcinoma, postoperative radiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2008 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 20 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients with risk factors of recurrence receive postoperative radiotherapy using intensive modulated radiation therapy (IMRT) or three-dimensional conformal radiation therapy (3DCRT). The clinical target volume includes tumor bed. The dose will be 50-60Gy/25-30f. Overall survival, local-recurrence free survival, disease free survival and toxicity need be observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hepatectomy plus radiotherapy | Experimental | Radiation: postoperative radiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- written informed consent provided
- 18~75 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| postoperative radiotherapyAlso: adjuvant radiotherapyIMRT or 3DCRT, 50-60Gy to the tumor bed | Radiation | hepatectomy plus radiotherapy |
Primary outcome
overall survival
Time frame: 3 year
the rate of overall survival for 3 year
3 secondary outcomes
local recurrence free survival
Time frame: 3 years
disease free survival
Time frame: 3 years
Number of Participants with Adverse Events
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2017.
- Derived from this study: PubMed 34097307Chen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing postoperative radiotherapy in people with Hepatocellular Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01456156, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2017.