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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5
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
Washington University School of Medicine
St Louis, Missouri, United States
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.
Time frame: Up through 6 months post-treatment (approximately 6 months and 2 weeks)
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Pre-treatment, six-weeks post treatment, and six months post-treatment
Number of Participants With Local Failure
Time frame: At six month follow-up (approximately 6 months and 2 weeks)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.