Back to resultsAdaptive MRI-Guided SBRT for Unresectable Primary or Oligometastatic Central Thorax and Abdominal Malignancies
Primary Purpose
Central Thorax Cancer, Liver Cancer, Non-Liver Abdominal Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MRI-guided stereotactive body radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Central Thorax Cancer
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1: Stereotactic body radiation therapy
Arm Description
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Tumor response rate
Local, in-field control rate
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.
Disease free survival rate
Overall survival rate
Patient-reported quality of life
Using the EORTC QLQ-C30
Full Information
NCT ID
NCT02264886
First Posted
October 8, 2014
Last Updated
December 7, 2016
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02264886
Brief Title
Adaptive MRI-Guided SBRT for Unresectable Primary or Oligometastatic Central Thorax and Abdominal Malignancies
Official Title
Pilot Study of Online, Adaptive MRI-Guided SBRT for Unresectable Primary or Oligometastatic Central Thorax and Abdominal Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Thorax Cancer, Liver Cancer, Non-Liver Abdominal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: Stereotactic body radiation therapy
Arm Type
Experimental
Arm Description
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).
Intervention Type
Radiation
Intervention Name(s)
MRI-guided stereotactive body radiation therapy
Other Intervention Name(s)
SBRT
Primary Outcome Measure Information:
Title
Feasibility of the online, adaptive, MRI-guided SBRT
Description
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.
Time Frame
Average time of 2 weeks
Secondary Outcome Measure Information:
Title
Tumor response rate
Time Frame
3 months
Title
Local, in-field control rate
Time Frame
6 months
Title
Progression free survival rate (PFS)
Description
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
Time Frame
6 months
Title
Disease free survival rate
Time Frame
6 months
Title
Overall survival rate
Time Frame
6 months
Title
Patient-reported quality of life
Description
Using the EORTC QLQ-C30
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Parag J Parikh, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Learn more about this trial
Adaptive MRI-Guided SBRT for Unresectable Primary or Oligometastatic Central Thorax and Abdominal Malignancies
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