Hepatocellular CarcinomaPhase 1NCT00848094
Radiation Dose Escalation Study for Advanced Liver Cancer
A Phase 1 study testing 3DCRT/IMRT in people with Hepatocellular Carcinoma, run by Fudan University.
Trial summary
The purpose of this clinical study is to determine the maximum tolerated dose (MTD) of 3-dimensional conformal radiation therapy (3-DCRT)/intensity modulated radiation therapy (IMRT) for locally advanced hepatocellular carcinoma (HCC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- 3DCRT/IMRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to May 2008
- Phase
- Phase 1
- 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
- Pathologically confirmed or clinically diagnosed HCC
- Surgically unsectable or medically inoperable diseases, or surgery declined by the patient
- Solitary intrahepatic lesion with diameter bigger than 5 cm, without extrahepatic and/or distant metastases
- Associated with cirrhosis of Child-Pugh A
- Karnofsky performance status (KPS) of ≥ 70
- Normal renal function and adequate bone marrow reservation
- Tolerate active breathing control (ABC)
Who cannot join
- Child-Pugh B or C liver cirrhosis score
- Previous radiotherapy to the liver
- Indistinct tumor boundary in CT/MRI image
About this study
Official title: Phase I Trial of Radiation Dose Escalation for Locally Advanced Hepatocellular Carcinoma
The purpose of this clinical study is to determine the maximum tolerated dose (MTD) of 3-dimensional conformal radiation therapy (3-DCRT)/intensity modulated radiation therapy (IMRT) for locally advanced hepatocellular carcinoma (HCC).
- Conditions
- Hepatocellular Carcinoma
- Being tested
- 3DCRT/IMRT
- Keywords
- hepatocellular carcinoma, radiation therapy, 3-dimensional conformal radiation therapy (3-DCRT), intensity modulated radiation therapy (IMRT), active breathing control
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3DCRT/IMRTRadiation
The starting radiation doses were the total tumor doses of 46 Gy in 2 Gy per fractions for arm I . Escalation was achieved by increasing the tumor dose of each cohort in increments of 4.0 Gy. Subsequent cohorts received higher doses up to a chosen maximum of 62 Gy for arm I.
3DCRT/IMRTRadiation
The starting radiation doses were the total tumor doses of 40 Gy in 2 Gy per fractions for arm II. Escalation was achieved by increasing the tumor dose of each cohort in increments of 4.0 Gy. Subsequent cohorts received higher doses up to a chosen maximum of 52 Gy for arm II.
| Study group | Role | What they receive |
|---|---|---|
| arm 1 | Other | Arm I: tumor diameter more than 5 cm and less than 10 cm. Receives: Radiation: 3DCRT/IMRT |
| arm 2 | Other | Arm II: tumor diameter no less than 10 cm. Receives: Radiation: 3DCRT/IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity was graded using the CTCAE 3.0. Dose-limiting toxicity was defined as acute ≥ grade 3 hepatic or gastrointestinal toxicity, or any grade 5 treatment-related adverse event, or late complication of radiation-induced liver disease.
Measured: 4 months
Secondary outcomes (1)
1,2 and 3 years survival
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2009 (estimated)
- Study startApr 2005
- Primary completionJan 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Investigators
- Guoliang Jiang, M.D., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00848094
- Sponsor's protocol ID
- LCR-003
- Status last verified
- Feb 2009
- First submitted
- 19 Feb 2009
- Last updated
- 20 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Radiation Dose Escalation for Locally Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00848094
- Acronym / sponsor ID
- LCR-003
- Conditions
- Hepatocellular Carcinoma
- Keywords
- hepatocellular carcinoma, radiation therapy, 3-dimensional conformal radiation therapy (3-DCRT), intensity modulated radiation therapy (IMRT), active breathing control
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 20 Feb 2009 (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.
The purpose of this clinical study is to determine the maximum tolerated dose (MTD) of 3-dimensional conformal radiation therapy (3-DCRT)/intensity modulated radiation therapy (IMRT) for locally advanced hepatocellular carcinoma (HCC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arm 1 | Other | Radiation: 3DCRT/IMRTArm I: tumor diameter more than 5 cm and less than 10 cm. |
| arm 2 | Other | Radiation: 3DCRT/IMRTArm II: tumor diameter no less than 10 cm. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pathologically confirmed or clinically diagnosed HCC
- Surgically unsectable or medically inoperable diseases, or surgery declined by the patient
- Solitary intrahepatic lesion with diameter bigger than 5 cm, without extrahepatic and/or distant metastases
- Associated with cirrhosis of Child-Pugh A
- Karnofsky performance status (KPS) of ≥ 70
Key exclusion criteria (3 listed)
- Child-Pugh B or C liver cirrhosis score
- Previous radiotherapy to the liver
- Indistinct tumor boundary in CT/MRI image
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 |
|---|---|---|
| 3DCRT/IMRTThe starting radiation doses were the total tumor doses of 46 Gy in 2 Gy per fractions for arm I . Escalation was achieved by increasing the tumor dose of each cohort in increments of 4.0 Gy. Subsequent cohorts received higher doses up to a chosen maximum of 62 Gy for arm I. | Radiation | arm 1 |
| 3DCRT/IMRTThe starting radiation doses were the total tumor doses of 40 Gy in 2 Gy per fractions for arm II. Escalation was achieved by increasing the tumor dose of each cohort in increments of 4.0 Gy. Subsequent cohorts received higher doses up to a chosen maximum of 52 Gy for arm II. | Radiation | arm 2 |
Primary outcome
Toxicity was graded using the CTCAE 3.0. Dose-limiting toxicity was defined as acute ≥ grade 3 hepatic or gastrointestinal toxicity, or any grade 5 treatment-related adverse event, or late complication of radiation-induced liver disease.
Time frame: 4 months
1 secondary outcome
1,2 and 3 years survival
Time frame: 4 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 20 Feb 2009.
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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.
Guoliang Jiang, M.D. principal investigator
Fudan University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 3DCRT/IMRT in people with Hepatocellular Carcinoma, run by Fudan University.
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 7 inclusion and 3 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 20 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Toxicity was graded using the CTCAE 3.0. Dose-limiting toxicity was defined as acute ≥ grade 3 hepatic or gastrointestinal toxicity, or any grade 5 treatment-related adverse event, or late complication of radiation-induced liver disease. (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2009.