Central Thorax CancerPhase 1NCT02264886
Adaptive MRI-Guided SBRT for Unresectable Primary or Oligometastatic Central Thorax and Abdominal Malignancies
A Phase 1 study testing MRI-guided stereotactive body radiation therapy in people with Central Thorax Cancer and Liver Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this research study is evaluate whether it's feasible to give radiation therapy using an MRI-guided adaptive technique. MRI-guided adaptive radiation therapy involves the adjustment or re-planning of treatment day by day while the participant is receiving treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Thorax Cancer, Liver Cancer, Non-Liver Abdominal Cancer
- What is being tested?
- MRI-guided stereotactive body radiation therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Dec 2016
- 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
- Oligometastatic or unresectable primary disease planned for SBRT with biopsy-proven primary disease histology of solid tumor categorization with the exception of small cell cancers.
- Must be deemed medically fit for SBRT to the liver or lung by the treating physician.
- At least 18 years of age.
- Karnofsky performance status > 60 (see Appendix A)
- Must have completed any systemic therapy at least one week prior to planned start of SBRT (two weeks preferred), and must have no plans to initiate systemic therapy for at least one week following end of SBRT (two weeks preferred).
- Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Who cannot join
- Primary disease of hematologic origin, lymphoma, or small cell cancer.
- Past history of radiotherapy within the projected treatment field of any of the disease sites to be treated by MRI-guided, online adaptive SBRT.
- Widespread progressive disease, i.e., more than 3 sites of progressive disease (more than 3 sites of disease are permitted provided there are no more than 3 sites of progressive disease).
- Currently receiving any other investigational agents.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant and/or breastfeeding. Patient must have a negative pregnancy test within 14 days of study entry.
- Medical contraindication to undergoing MR imaging.
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: Pilot Study of Online, Adaptive MRI-Guided SBRT for Unresectable Primary or Oligometastatic Central Thorax and Abdominal Malignancies
The purpose of this research study is evaluate whether it's feasible to give radiation therapy using an MRI-guided adaptive technique. MRI-guided adaptive radiation therapy involves the adjustment or re-planning of treatment day by day while the participant is receiving treatment. The adaptive technique has previously been used in a different fashion to adjust the treatment plan after the fact, but using MRI scanning to re-plan treatment while the participant is still on the table is a new way of using the adaptive technique. This may allow doctors to use more radiation to treat the tumor while better protecting normal tissues. A special radiation treatment machine incorporates both an MRI scanner and radiation treatment devices so that the planning and treatment can be done using the same machine.
Read the detailed description
In this trial, the feasibility of delivering online, adaptive MRI-guided stereotactic body radiation therapy for oligometastatic disease using a novel, integrated Co-60-MRI machine will be evaluated. To best assess this technology, we will focus on three specific oligometastatic disease sites that have historically highlighted the limitations of SBRT. Specifically, we will enroll patients with oligometastatic disease of the central thorax, liver, and non-liver abdomen to receive adaptive, MRI-guided SBRT with MRI simulation and MRI treatment gating. Patients will be treated in five fractions over one to two weeks. By adhering to strict normal tissue constraints, expected toxicity will be within the current standard of care, but allow adaptation based on daily anatomic changes. The prescription dose will be determined based on above hard normal tissue constraints, and capped at 15 Gy per fraction. Although our long-term goal will be to achieve improved local control and disease-free survival with reduced toxicity, the present study will be driven by short-term goals of demonstrating feasibility of an on-table adaptive approach, which has never previously been reported.
- Being tested
- MRI-guided stereotactive body radiation therapy
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI-guided stereotactive body radiation therapyRadiation
Also called SBRT
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Stereotactic body radiation therapy | Experimental | Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments.
All patients will undergo MRI simulation in positioning appropriate for the specific treatment site. When medically feasible and applicable, patients will be simulated with IV and small bowel contrast (for non-thorax cases). Receives: Radiation: MRI-guided stereotactive body radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the online, adaptive, MRI-guided SBRT
Feasibility is determined that confirming that the treatment can be delivered with less than 80 minutes total treatment (on table) time, for more than 75% of cases where treatment adaptation is indicated.
Measured: Average time of 2 weeks
Secondary outcomes (6)
Tumor response rate
Measured: 3 months
Local, in-field control rate
Measured: 6 months
Progression free survival rate (PFS)
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
Measured: 6 months
Disease free survival rate
Measured: 6 months
Overall survival rate
Measured: 6 months
Patient-reported quality of life
Using the EORTC QLQ-C30
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startJan 2015
- Primary completionJun 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Thorax CancerStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Parag J Parikh, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02264886
- Sponsor's protocol ID
- 201410002
- Status last verified
- Dec 2016
- First submitted
- 8 Oct 2014
- Last updated
- 9 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Online, Adaptive MRI-Guided SBRT for Unresectable Primary or Oligometastatic Central Thorax and Abdominal Malignancies
- ClinicalTrials.gov ID
- NCT02264886
- Acronym / sponsor ID
- 201410002
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 15 Oct 2014 (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 research study is evaluate whether it's feasible to give radiation therapy using an MRI-guided adaptive technique. MRI-guided adaptive radiation therapy involves the adjustment or re-planning of treatment day by day while the participant is receiving treatment. The adaptive technique has previously been used in a different fashion to adjust the treatment plan after the fact, but using MRI scanning to re-plan treatment while the participant is still on the table is a new way of using the adaptive technique. This may allow doctors to use more radiation to treat the tumor while better protecting normal tissues. A special radiation treatment machine incorporates both an MRI scanner and radiation treatment devices so that the planning and treatment can be done using the same machine.
Detailed description
In this trial, the feasibility of delivering online, adaptive MRI-guided stereotactic body radiation therapy for oligometastatic disease using a novel, integrated Co-60-MRI machine will be evaluated. To best assess this technology, we will focus on three specific oligometastatic disease sites that have historically highlighted the limitations of SBRT. Specifically, we will enroll patients with oligometastatic disease of the central thorax, liver, and non-liver abdomen to receive adaptive, MRI-guided SBRT with MRI simulation and MRI treatment gating. Patients will be treated in five fractions over one to two weeks. By adhering to strict normal tissue constraints, expected toxicity will be within the current standard of care, but allow adaptation based on daily anatomic changes. The prescription dose will be determined based on above hard normal tissue constraints, and capped at 15 Gy per fraction. Although our long-term goal will be to achieve improved local control and disease-free survival with reduced toxicity, the present study will be driven by short-term goals of demonstrating feasibility of an on-table adaptive approach, which has never previously been reported.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Stereotactic body radiation therapy | Experimental | Radiation: MRI-guided stereotactive body radiation therapyRadiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments. All patients will undergo MRI simulation in positioning appropriate for the specific treatment site. When medically feasible and applicable, patients will be simulated with IV and small bowel contrast (for non-thorax cases). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Oligometastatic or unresectable primary disease planned for SBRT with biopsy-proven primary disease histology of solid tumor categorization with the exception of small cell cancers.
- Must be deemed medically fit for SBRT to the liver or lung by the treating physician.
- At least 18 years of age.
- Karnofsky performance status > 60 (see Appendix A)
- Must have completed any systemic therapy at least one week prior to planned start of SBRT (two weeks preferred), and must have no plans to initiate systemic therapy for at least one week following end of SBRT (two weeks preferred).
Key exclusion criteria (7 listed)
- Primary disease of hematologic origin, lymphoma, or small cell cancer.
- Past history of radiotherapy within the projected treatment field of any of the disease sites to be treated by MRI-guided, online adaptive SBRT.
- Widespread progressive disease, i.e., more than 3 sites of progressive disease (more than 3 sites of disease are permitted provided there are no more than 3 sites of progressive disease).
- Currently receiving any other investigational agents.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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 |
|---|---|---|
| MRI-guided stereotactive body radiation therapyAlso: SBRT | Radiation | Arm 1: Stereotactic body radiation therapy |
Primary outcome
Feasibility of the online, adaptive, MRI-guided SBRT
Time frame: Average time of 2 weeks
Feasibility is determined that confirming that the treatment can be delivered with less than 80 minutes total treatment (on table) time, for more than 75% of cases where treatment adaptation is indicated.
6 secondary outcomes
Tumor response rate
Time frame: 3 months
Local, in-field control rate
Time frame: 6 months
Progression free survival rate (PFS)
Time frame: 6 months
Disease free survival rate
Time frame: 6 months
Overall survival rate
Time frame: 6 months
Patient-reported quality of life
Time frame: 6 months
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 9 Dec 2016.
- 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 J 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 MRI-guided stereotactive body radiation therapy in people with Central Thorax Cancer and Liver Cancer, 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 6 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 9 Dec 2016. 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?
Feasibility of the online, adaptive, MRI-guided SBRT (time frame: Average time of 2 weeks). 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 9 Dec 2016.