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2017-01-19
2018-03-19
2018-03-19
5
NCT02950025
Washington University School of Medicine
Washington University School of Medicine
INTERVENTIONAL
Daily Online Adaptation Versus Localization for MRI-Guided SBRT for Unresectable Primary or Oligometastatic Abdominal Malignancies
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2016-10-27 | 2019-02-26 | 2019-03-26 |
2016-10-27 | 2019-02-26 | 2019-04-03 |
2016-10-31 | 2019-03-20 | 2019-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: Online non-adaptive MRI-guided SBRT * 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, del | DEVICE: Online, non-adaptive MR-guided SBRT
OTHER: European Organization for Research and Treatment of Cancer (EORTC) QLQ-30
|
| EXPERIMENTAL: Arm B: Online-Adaptive MRI-guided SBRT * 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, del | DEVICE: Online, adaptive MR-guided SBRT
OTHER: European Organization for Research and Treatment of Cancer (EORTC) QLQ-30
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Tumor Response Rate | * Tumor response rate = rate of participants who have complete or partial response at the six month follow-up * Complete Response (CR): Disappearance of the target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. * Partial Response (PR): At least a 30% decrease in the (sum of the) diameter of the target lesion(s), taking as reference the baseline sum diameters. | At six month follow-up (approximately 6 months and 2 weeks) |
| Progression-free Survival (PFS) Rate | * PFS rate - the number of participants who have not progressed and/or died at the six-month follow-up * Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. * Please note that the planned statistical analysis wasn't able to be performed due to small sample size: Utilizing Kaplan-Meier methodology | At six month follow-up (approximately 6 months and 2 weeks)-up |
| Disease Free Survival Rate | * Disease free survival rate = the number of participants who are disease free (without any signs or symptoms of cancer) at the six-month follow-up * Please note that the planned statistical analysis wasn't able to be performed due to small sample size: Utilizing Kaplan-Meier methodology. | At six month follow-up (approximately 6 months and 2 weeks) |
| Overall Survival (OS) Rate | * Overall survival rate - number of participants alive at the six-month follow-up * Please note that the planned statistical analysis wasn't able to be performed due to small sample size: Utilizing Kaplan-Meier methodology. | 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 | * Utilize both paired t-tests and repeated measures ANOVA to analyze QOL data (this was unable to be performed due to the small sample size) * The question asked the participant "how would you rate your quality of life during the past week?" * The scale ranges from 1=very poor to 7 = excellent. The higher the score the better the quality of life. | Pre-treatment, six-weeks post treatment, and six months post-treatment |
| Number of Participants With Local Failure | At six month follow-up (approximately 6 months and 2 weeks) |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
