A Phase 2 interventional study of Online, adaptive MR-guided SBRT and Online, non-adaptive MR-guided SBRT in Pancreatic Cancer, Pancreas Cancer and Cancer of the Pancreas, sponsored by Washington University School of Medicine. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-03.
Sponsored by Washington University School of Medicine · Phase 2, Interventional, and Treatment
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.
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Exclusion Criteria:
* 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
Device: Online, non-adaptive MR-guided SBRT · Other: European Organization for Research and Treatment of Cancer (EORTC) QLQ-30
* 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
Device: Online, adaptive MR-guided SBRT · Other: European Organization for Research and Treatment of Cancer (EORTC) QLQ-30
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
Also known as: EORTC QLQ-30
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)
The study opened to participant enrollment on 01/19/2017 and closed to participant enrollment on 08/13/2018.
| Milestone | Arm A: Online Non-adaptive MRI-guided SBRT | Arm B: Online-Adaptive MRI-guided SBRT |
|---|---|---|
| Started | 2 | 3 |
| Completed | 2 | 3 |
| Not completed | 0 | 0 |
* 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.
| adverse event | Arm A: Online Non-adaptive MRI-guided SBRT | Arm B: Online-Adaptive MRI-guided SBRT |
|---|---|---|
| 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 | 0 | 1 |
* 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.
| Participants | Arm A: Online Non-adaptive MRI-guided SBRT | Arm B: Online-Adaptive MRI-guided SBRT |
|---|---|---|
| Tumor Response Rate | 2 | 0 |
* 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
| Participants | Arm A: Online Non-adaptive MRI-guided SBRT | Arm B: Online-Adaptive MRI-guided SBRT |
|---|---|---|
| Progression-free Survival (PFS) Rate | 2 | 3 |
* 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.
| Participants | Arm A: Online Non-adaptive MRI-guided SBRT | Arm B: Online-Adaptive MRI-guided SBRT |
|---|---|---|
| Disease Free Survival Rate | 0 | 0 |
* 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.
| Participants | Arm A: Online Non-adaptive MRI-guided SBRT | Arm B: Online-Adaptive MRI-guided SBRT |
|---|---|---|
| Overall Survival (OS) Rate | 2 | 3 |
* 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.
| score on a scale | Arm A: Online Non-adaptive MRI-guided SBRT | Arm B: Online-Adaptive MRI-guided SBRT |
|---|---|---|
| Pre-treatment | 5 (5 to 5) | 5 (2 to 6) |
| 6-weeks post treatment | 6 (5 to 7) | 4 (4 to 4) |
| 6 months post treatment | 6 (6 to 6) | 3 (3 to 4) |
| Participants | Arm A: Online Non-adaptive MRI-guided SBRT | Arm B: Online-Adaptive MRI-guided SBRT |
|---|---|---|
| Number of Participants With Local Failure | 0 | 0 |
Collected over Adverse events were tracked for 6 months following the last day of SBRT. Please note, only acute adverse events were tracked. For the purposes of this protocol, adverse events collected and documented are non-hematologic acute grade 3 or higher toxicities that did not predate SBRT and are probably or definitely attributable to treatment.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A: Online Non-adaptive MRI-guided SBRT | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Arm B: Online-Adaptive MRI-guided SBRT | 0/3 (0%) | 1/3 (33.3%) | 1/3 (33.3%) |
| Event | Arm A: Online Non-adaptive MRI-guided SBRT | Arm B: Online-Adaptive MRI-guided SBRT |
|---|---|---|
| Duodenal ulcerGastrointestinal disorders | 0/2 | 1/3 |
| Event | Arm A: Online Non-adaptive MRI-guided SBRT | Arm B: Online-Adaptive MRI-guided SBRT |
|---|---|---|
| AnemiaBlood and lymphatic system disorders | 0/2 | 1/3 |
| Upper gastrointestinal hemorrhageGastrointestinal disorders | 0/2 | 1/3 |
| FatigueGeneral disorders | 0/2 | 1/3 |
| Lung infectionInfections and infestations | 0/2 | 1/3 |
| Lymphocyte count decreasedInvestigations | 0/2 | 1/3 |
| HyponatremiaMetabolism and nutrition disorders | 0/2 | 1/3 |
| Generalized muscle weaknessMusculoskeletal and connective tissue disorders | 0/2 | 1/3 |
| Age, Continuous(years) | Arm A: Online Non-adaptive MRI-guided SBRT | Arm B: Online-Adaptive MRI-guided SBRT | Total |
|---|---|---|---|
| Median | 68.5 (62 to 75) | 85 (56 to 87) | 75 (56 to 87) |
| Sex: Female, Male(Participants) | Arm A: Online Non-adaptive MRI-guided SBRT | Arm B: Online-Adaptive MRI-guided SBRT | Total |
|---|---|---|---|
| Female | 2 | 1 | 3 |
| Male | 0 | 2 | 2 |
| Ethnicity (NIH/OMB)(Participants) | Arm A: Online Non-adaptive MRI-guided SBRT | Arm B: Online-Adaptive MRI-guided SBRT | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 2 | 3 | 5 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Arm A: Online Non-adaptive MRI-guided SBRT | Arm B: Online-Adaptive MRI-guided SBRT | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 1 | 3 | 4 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Arm A: Online Non-adaptive MRI-guided SBRT | Arm B: Online-Adaptive MRI-guided SBRT | Total |
|---|---|---|---|
| United States | 2 | 3 | 5 |
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Washington University School of Medicine