Carcinoma, HepatocellularPhase 1NCT01668134
Stereotactic Body Radiotherapy for Hepatocellular Carcinoma, and Intrahepatic Cholangiocarcinoma
A Phase 1 study testing Stereotactic radiation in people with Carcinoma, Hepatocellular and Intrahepatic Cholangiocarcinoma, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This study is being done to determine if targeted radiation therapy (stereotactic) can be given to treat liver cancer, for patient who are unable to undergo surgery, over a short period of time with a small amount of side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular, Intrahepatic Cholangiocarcinoma
- What is being tested?
- Stereotactic radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2009to 22 Dec 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Karnofsky Performance Status of ≥ 60
- Pathologically confirmed IHC or HCC. (Pathology not required for HCC if the lesion enhances typically on MRI and the patient is evaluated by liver transplant surgery team and thought to have HCC.)
- 4 or less separate intrahepatic lesions, with at least one lesion that is able to be followed by EASL Criteria.
- Local surgical resection is not possible due to tumor or patient factors
- Limited metastatic disease is allowed if the volume of metastatic disease does not exceed the volume of primary disease.
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- Prior TACE allowed if stopped/completed at least 2 weeks prior to enrollment
- Prior chemotherapy except Sorafenib allowed if stopped/completed at least 2 weeks prior to enrollment
- Prior Sorafenib allowed if stopped/completed at least seven days prior to enrollment.
- Able to provide signed informed consent
Who cannot join
- Childs-Pugh score 9 or more
- ALT or AST ≥ 6 x upper limit of normal
- Prior history of abdominal irradiation
- Women who are pregnant or nursing
- Scheduled to undergo chemotherapy except Sorafenib at the time when radiation therapy will be given, or for up to 4 weeks after completion of radiation therapy.
- Scheduled to undergo Sorafenib within seven days of when radiation therapy will be delivered, or for up to 2 weeks after completion of radiation therapy.
- Undergone prior radiation therapy to the abdomen.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Feasibility Study of Stereotactic Body Radiotherapy for Hepatocellular Carcinoma, and Intrahepatic Cholangiocarcinoma
This study is being done to determine if targeted radiation therapy (stereotactic) can be given to treat liver cancer, for patient who are unable to undergo surgery, over a short period of time with a small amount of side effects.
- Being tested
- Stereotactic radiation
- Medical subject headings
- Carcinoma, Hepatocellular, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic radiationRadiation
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic radiation | Experimental | Not described Receives: Radiation: Stereotactic radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stereotactic radiation therapy (either photon or proton) can be delivered to the liver with a less than 10% 3-month incidence of Grade 4 study related toxicity.
Measured: Up to 90 days after end of radiation therapy
Secondary outcomes (4)
Measure the late toxicity associated with using stereotactic radiation therapy in patients with unresectable HCC and IHC.
Measured: Up to 60 days after end of radiation therapy
Measure the local recurrence rates associated with using SBRT in patients with unresectable HCC and IHC.
Measured: Time of treatment until recurrance or progressive disease as measured by CT/MR from baseline to recurrance or progressive disease
Measure the overall survival rates associated with using SBRT in patients with unresectable HCC and IHC.
Measured: Baseline to time of death
Measure the response rates associated with using SBRT in patients with resectable HCC and IHC
Measured: Baseline to the first date of recurrance or progressive disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study start16 Dec 2009
- Primary completion30 Aug 2014
- Study completion22 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Parag Parikh, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668134
- Sponsor's protocol ID
- 09-1345 / 201107319
- Status last verified
- Feb 2017
- First submitted
- 8 Aug 2012
- Last updated
- 20 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Stereotactic Body Radiotherapy for Hepatocellular Carcinoma, and Intrahepatic Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT01668134
- Acronym / sponsor ID
- 09-1345 / 201107319
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 16 Dec 2009 (actual)
- Primary completion
- 30 Aug 2014 (actual)
- Study completion
- 22 Dec 2015 (actual)
- First posted
- 17 Aug 2012 (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.
This study is being done to determine if targeted radiation therapy (stereotactic) can be given to treat liver cancer, for patient who are unable to undergo surgery, over a short period of time with a small amount of side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic radiation | Experimental | Radiation: Stereotactic radiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18
- Karnofsky Performance Status of ≥ 60
- Pathologically confirmed IHC or HCC. (Pathology not required for HCC if the lesion enhances typically on MRI and the patient is evaluated by liver transplant surgery team and thought to have HCC.)
- 4 or less separate intrahepatic lesions, with at least one lesion that is able to be followed by EASL Criteria.
- Local surgical resection is not possible due to tumor or patient factors
Key exclusion criteria (7 listed)
- Childs-Pugh score 9 or more
- ALT or AST ≥ 6 x upper limit of normal
- Prior history of abdominal irradiation
- Women who are pregnant or nursing
- Scheduled to undergo chemotherapy except Sorafenib at the time when radiation therapy will be given, or for up to 4 weeks after completion of radiation therapy.
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 |
|---|---|---|
| Stereotactic radiation | Radiation | Stereotactic radiation |
Primary outcome
Stereotactic radiation therapy (either photon or proton) can be delivered to the liver with a less than 10% 3-month incidence of Grade 4 study related toxicity.
Time frame: Up to 90 days after end of radiation therapy
4 secondary outcomes
Measure the late toxicity associated with using stereotactic radiation therapy in patients with unresectable HCC and IHC.
Time frame: Up to 60 days after end of radiation therapy
Measure the local recurrence rates associated with using SBRT in patients with unresectable HCC and IHC.
Time frame: Time of treatment until recurrance or progressive disease as measured by CT/MR from baseline to recurrance or progressive disease
Measure the overall survival rates associated with using SBRT in patients with unresectable HCC and IHC.
Time frame: Baseline to time of death
Measure the response rates associated with using SBRT in patients with resectable HCC and IHC
Time frame: Baseline to the first date of recurrance or progressive disease
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 2017.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Parag Parikh, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Stereotactic radiation in people with Carcinoma, Hepatocellular and Intrahepatic Cholangiocarcinoma, run by Washington University School of Medicine at 1 site in United States.
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 10 inclusion and 7 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 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 United States. 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.
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?
Stereotactic radiation therapy (either photon or proton) can be delivered to the liver with a less than 10% 3-month incidence of Grade 4 study related toxicity. (time frame: Up to 90 days after end of radiation therapy). 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 2017.