Hepatocellular CarcinomaNCT02460835

A Pilot Study of Individualized Adaptive Radiation Therapy for Hepatocellular Carcinoma

A study testing Adaptive Radiation Therapy in people with Hepatocellular Carcinoma, run by University of Michigan Rogel Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatocellular Carcinoma
What is being tested?: Adaptive Radiation Therapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 77 participants
Where: 1 siteUnited States
Study dates: 26 Jan 2016to 20 Jan 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Patients must have hepatocellular carcinoma.
Patients must not have extrahepatic cancer.
Patients must not be eligible for a curative liver resection or have refused resection
Patients must have recovered from the acute effects of prior liver-directed therapy and 4 weeks must have passed since the last procedure and protocol therapy.
Patients must have a Zubrod performance status of less than or equal to 2 (Zubrod performance status is a measure that attempts to quantify a cancer patients' general well-being. Scores run from 0 to 5 where 0 denotes normal activity and 5 denotes death).
Patients must be 18 years of age or older.
Patients must have adequate organ function.
Patients must understand and be willing to sign an IRB (Institutional Review Board) approved informed consent form.

Who cannot join

Patients with known allergies to intravenous iodinated contrast agents.
Patients with a contraindication to contrast-enhanced MRI are excluded.

Trial locations and contacts

1 site in 1 country.

United States1 site

Rogel Comprehensive Cancer Center
Ann Arbor, Michigan, 48187

Other trials in United States

About this study

This is a pilot single arm study with the primary endpoints of feasibility and preliminary estimates of safety and efficacy. This protocol builds on over 25 years of experience with high dose liver RT (Radiation Therapy), and in particular adaptive RT aimed at adjusting the global radiation dose based on a patient's measured sensitivity to treatment. This current protocol uses functional imaging and specialized radiation planning techniques to spare highly functional portions of the liver to preserve function. The investigators feel this will further improve the safety and efficacy of RT for all patients by customizing treatments to each. If this approach is promising, the investigators will proceed to a phase II randomized study of standard versus spatially and dosimetrically adapted RT.

Conditions: Hepatocellular Carcinoma
Being tested: Adaptive Radiation Therapy
Medical subject headings: Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Adaptive Radiation TherapyRadiation

Study groups in NCT02460835
Study group	Role	What they receive
Adaptive Radiation Therapy	Experimental	Not described Receives: Radiation: Adaptive Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

The Proportion of Patients for Whom the Intended Treatment Was Feasible
The primary aim of the trial is feasibility which is defined as the ability to successfully deliver the full treatment including all adaptations and in particular the perfusion-based planning and replanning.
Measured: At end of treatment; up to ~3 months
Percentage of Patients With Change in Child Pugh Score >= 2
Rate of liver decompensation reported as the percentage of patients with a change in Child Pugh score of greater than or equal to 2 within 6 months of SBRT.
Measured: Baseline to approximately 6 months after initiation of SBRT
Median Time to Local Progression
The primary efficacy endpoint is local control, measured as the duration of time from start of treatment to time of progression of the treated (target) lesion(s). Patients with no evidence of local progression at the time of data analysis will be censored at the last date on which they were evaluated for local progression. Local progression will be summarized with Kaplan-Meier curves and reported with 95% confidence intervals.
Measured: 24 months

Secondary outcomes (4)

Median Time to Progression
Defined as the duration of time from start of treatment to time of progression.
Measured: 24 months
Change in ALBI Scores
Liver decompensation assessed by change in ALBI score > 0.5 from baseline.
Measured: Approximately 6 months
Incidence of Grade 3 Gastrointestinal (GI) Bleeding Toxicities
Grade 3 GI bleeding assessed via the NCI CTCAE version 4.0.
Measured: Approximately 6 months
Overall Survival
Overall survival (OS) is defined as the duration of time from start of treatment to death.
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jan 201620 Jan 2022

First posted2 Jun 2015 (estimated)
Study start26 Jan 2016
Primary completion20 Jan 2022
Study completion20 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
More trials run by University of Michigan Rogel Cancer CenterThe 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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 77 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02460835
Sponsor's protocol ID: UMCC 2015.039
Other IDs: HUM00098022
Status last verified: Nov 2023
First submitted: 28 May 2015
Last updated: 15 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
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The Vanguard Study: Testing a New Way to Screen for Cancer
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Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma

All Hepatocellular Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study of Individualized Adaptive Radiation Therapy for Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT02460835
Acronym / sponsor ID: UMCC 2015.039
Conditions: Hepatocellular Carcinoma
Study type: Interventional
Recruitment status: Completed
Enrolment: 77 participants (actual)
Lead sponsor: University of Michigan Rogel Cancer CenterUniversity, hospital or other
Collaborators: National Institutes of Health (NIH)
Study start: 26 Jan 2016 (actual)
Primary completion: 20 Jan 2022 (actual)
Study completion: 20 Jan 2022 (actual)
First posted: 2 Jun 2015 (estimated)
Results: Posted 15 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Adaptive Radiation Therapy	Experimental	Radiation: Adaptive Radiation Therapy

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Patients must have hepatocellular carcinoma.
Patients must not have extrahepatic cancer.
Patients must not be eligible for a curative liver resection or have refused resection
Patients must have recovered from the acute effects of prior liver-directed therapy and 4 weeks must have passed since the last procedure and protocol therapy.
Patients must have a Zubrod performance status of less than or equal to 2 (Zubrod performance status is a measure that attempts to quantify a cancer patients' general well-being. Scores run from 0 to 5 where 0 denotes normal activity and 5 denotes death).

Key exclusion criteria (2 listed)

Patients with known allergies to intravenous iodinated contrast agents.
Patients with a contraindication to contrast-enhanced MRI are excluded.

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
Adaptive Radiation Therapy	Radiation	Adaptive Radiation Therapy

Primary outcome

The Proportion of Patients for Whom the Intended Treatment Was Feasible
Time frame: At end of treatment; up to ~3 months
The primary aim of the trial is feasibility which is defined as the ability to successfully deliver the full treatment including all adaptations and in particular the perfusion-based planning and replanning.
Percentage of Patients With Change in Child Pugh Score >= 2
Time frame: Baseline to approximately 6 months after initiation of SBRT
Rate of liver decompensation reported as the percentage of patients with a change in Child Pugh score of greater than or equal to 2 within 6 months of SBRT.
Median Time to Local Progression
Time frame: 24 months
The primary efficacy endpoint is local control, measured as the duration of time from start of treatment to time of progression of the treated (target) lesion(s). Patients with no evidence of local progression at the time of data analysis will be censored at the last date on which they were evaluated for local progression. Local progression will be summarized with Kaplan-Meier curves and reported with 95% confidence intervals.

4 secondary outcomes

Median Time to Progression
Time frame: 24 months
Change in ALBI Scores
Time frame: Approximately 6 months
Incidence of Grade 3 Gastrointestinal (GI) Bleeding Toxicities
Time frame: Approximately 6 months
Overall Survival
Time frame: 24 months

Results and safety

Results posted to the registry on 15 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adaptive Radiation Therapy	77	56

Primary outcome: The Proportion of Patients for Whom the Intended Treatment Was Feasible

Time frame: At end of treatment; up to ~3 months. Count of participants. Unit: Participants

Measure	Adaptive Radiation Therapy n = 77
Value	70

Population analysed: 77 subjects enrolled, 70 subjects treated

Primary outcome: Percentage of Patients With Change in Child Pugh Score >= 2

Time frame: Baseline to approximately 6 months after initiation of SBRT. Count of participants. Unit: Participants

Measure	Adaptive Radiation Therapy n = 56
Value	12

Population analysed: 77 subjects enrolled, 70 subjects treated, 56 eligible for analysis (14 were excluded: 10- fractionated RT, 2- unable to complete follow up, 2- withdrew)

Primary outcome: Median Time to Local Progression

Time frame: 24 months. Median (95% Confidence Interval). Unit: Months

Measure	Adaptive Radiation Therapy n = 9
Value	17.4 (4.93 to 25.27)

Population analysed: 77 subjects enrolled, 70 subjects treated, 9 eligible for analysis

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 2 years after last dose of study treatment. Data was collected over 6 years.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adaptive Radiation Therapy	6 of 77 (7.8%)	67 of 77 (87%)	19 of 77

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hepatocellular Carcinoma

RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma

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.

Theodore Lawrence, M.D., Ph.D. principal investigator

Rogel Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Adaptive Radiation Therapy in people with Hepatocellular Carcinoma, run by University of Michigan Rogel Cancer Center 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 8 inclusion and 2 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 15 Nov 2023. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Proportion of Patients for Whom the Intended Treatment Was Feasible (time frame: At end of treatment; up to ~3 months). The study lists 3 primary outcomes in all. 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 NCT02460835.

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 15 Nov 2023.