Study Stopped
Low accrual
Daily Online Adaptation Versus Localization for MRI-Guided SBRT for Unresectable Primary or Oligometastatic Abdominal Malignancies
A Randomized Controlled Phase II Study of Daily Online Adaptation Versus Localization for MRI-Guided SBRT for Unresectable Primary or Oligometastatic Abdominal Malignancies
1 other identifier
interventional
5
1 country
1
Brief Summary
In light of this new technology and preliminary findings of low toxicity of online, adaptive, magnetic resonance (M)-guided stereotactic radiation on a single arm prospective study, the investigators propose to compare this technique to online MR-guided stereotactic body radiation therapy (SBRT) without adaptation. Online plan adaptation increases treatment times for patients and comprises an increased burden on technical and clinical staff. Although preliminary trial results are encouraging, it remains unclear if the dosimetric benefits of online-adaptive planning studies will translate to measurable improvements in clinical outcomes that merit its routine use. In our preliminary study, plan adaptation was most often required when tumors were adjacent to the gastrointestinal tract (the esophagus to the sigmoid colon), as those structures were most commonly the dose-limiting structures and were noted to change in location on a day-to-day basis. For these reasons, abdominal disease sites have historically highlighted the limitations of SBRT. Specifically, the investigators will enroll patients with oligometastatic or unresectable primary disease of the non-liver abdomen to a randomized, prospective trial. Patients will be randomized to one of two treatment arms, in which they will receive either online-adaptive, MRI-guided SBRT or non-adaptive MRI-guided SBRT. Both patient groups will undergo MRI simulation and MRI treatment localization with online MR monitoring and/or gating. All patients will be treated in five fractions over one to two weeks. By adhering to strict normal tissue constraints, the investigators expect toxicity to be within the current standard of care for the non-adaptive arm, with reduction in toxicity in the arm of patients who undergo adaptation based on daily anatomic changes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 pancreatic-cancer
Started Jan 2017
Shorter than P25 for phase_2 pancreatic-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2016
CompletedFirst Posted
Study publicly available on registry
October 31, 2016
CompletedStudy Start
First participant enrolled
January 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 19, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 19, 2018
CompletedResults Posted
Study results publicly available
March 20, 2019
CompletedApril 3, 2019
March 1, 2019
1.2 years
October 27, 2016
February 26, 2019
March 26, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Grade 3 or Greater Toxicity Occurring in Patients Receiving Online, Adaptive, MRI-guided SBRT to the Abdomen and in Patients Receiving Non-adaptive SBRT
* The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting. * Grade 3 or higher toxicities that did not predate SBRT and are probably or definitely attributable to treatment * Please note that the following statistical analysis was not performed due to small sample size: Statistical analysis will be powered to detect a reduction of toxicity from 35% Grade 3 or greater toxicity to 10% Grade 3 or greater toxicity using online-adaptive therapy. Statistical analysis will be one-sided test for independent proportions.
Up through 6 months post-treatment (approximately 6 months and 2 weeks)
Secondary Outcomes (6)
Tumor Response Rate
At six month follow-up (approximately 6 months and 2 weeks)
Progression-free Survival (PFS) Rate
At six month follow-up (approximately 6 months and 2 weeks)-up
Disease Free Survival Rate
At six month follow-up (approximately 6 months and 2 weeks)
Overall Survival (OS) Rate
At six month follow-up (approximately 6 months and 2 weeks)
Patient Reported Overall Quality of Life During the Past Week as Measured by EORTC QLQ-C30 Quality of Life
Pre-treatment, six-weeks post treatment, and six months post-treatment
- +1 more secondary outcomes
Study Arms (2)
Online non-adaptive MRI-guided SBRT
ACTIVE COMPARATOR* All patients will be initially planned for stereotactic body radiation therapy to a minimum dose of 50Gy in five fractions to the planning target volume (PTV) * 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 both CT and MRI simulation in positioning appropriate for the specific treatment site * Quality of life questionnaire baseline, 6 weeks after treatment conclusion, and 6 months after treatment conclusion
Arm B: Online-Adaptive MRI-guided SBRT
EXPERIMENTAL* All patients will be initially planned for stereotactic body radiation therapy to a minimum dose of 50Gy in five fractions to the planning target volume (PTV) * 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 both CT and MRI simulation in positioning appropriate for the specific treatment site * When patients present for their first SBRT treatment session, the treating physician will evaluate their individual anatomy to determine if adaptive planning is indicated. Patients randomized to the online-adaptive treatment planning arm will have all tumor volumes and critical structures within 3 axial slices of the PTV re-contoured on the MR-localization image of the day * Quality of life questionnaire baseline, 6 weeks after treatment conclusion, and 6 months after treatment conclusion
Interventions
Patients randomized to the online-adaptive treatment planning arm will have all tumor volumes and critical structures within 3 axial slices of the PTV re-contoured on the MR-localization image of the day. The estimated delivered dose should be calculated using the software on the console. An adapted radiation therapy plan should be generated
Patients will not have online-adaptive treatment planning
* 30 questions * 28 questions about various health issues with answers ranging from 1=Not At All to 4 = Very Much * 1 question asking about overall health with answers ranging from 1=very poor to 7 excellent * 1 question asking about overall quality of life with answers ranging from 1=very poor to 7=excellent
Eligibility Criteria
You may qualify if:
- Oligometastatic disease or unresectable primary abdominal malignancy with biopsy-proven primary disease histology of solid tumor categorization. Patients with a diagnosis of hepatocellular carcinoma do not require a biopsy.
- No more than three progressive sites of disease, with at least one of the disease sites to be deemed suitable for treatment with MRI-guided, online adaptive SBRT to the non-liver abdomen as per radiation oncology evaluation.
- Must be treated per protocol to lesion(s) of a single abdominal site that can reasonably be encompassed within a single treatment field. Treatment of additional site(s) outside of the abdomen while the patient is on trial is acceptable.
- The treated lesion must be within 2 cm of the abdominal gastrointestinal tract (abdominal esophagus to sigmoid colon) on the basis of cross sectional imaging study such as computed tomography (CT), positron emission tomography (PET)/CT, or MRI.
- Must be deemed medically fit for SBRT by the treating physician.
- At least 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- 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).
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- Able to understand and willing to sign an Institutional Review Board (IRB) approved, written informed consent document (or that of legally authorized representative, if applicable).
You may not qualify if:
- Primary disease of hematologic origin, lymphoma, or small cell cancer.
- Past history of external beam radiotherapy within the projected treatment field of any of the disease sites to be treated by MRI-guided, online adaptive SBRT.
- 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, or cardiac arrhythmia.
- Pregnant and/or breastfeeding. Patient must have a negative pregnancy test within 14 days of study entry.
- Medical contraindication to undergoing MR imaging.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Please note that the Principal Investigator (PI) changed for the study after all patients were off follow-up and the protocol title page didn't change at that time. This is why the listed PI is different than the PI on the title page of protocol.
Results Point of Contact
- Title
- Michael C. Roach, M.D.
- Organization
- Washington University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Michael C Roach, M.D.
Washington University School of Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2016
First Posted
October 31, 2016
Study Start
January 19, 2017
Primary Completion
March 19, 2018
Study Completion
March 19, 2018
Last Updated
April 3, 2019
Results First Posted
March 20, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share