Pancreatic CancerPhase 2NCT02950025
Daily Online Adaptation Versus Localization for MRI-Guided SBRT for Unresectable Primary or Oligometastatic Abdominal Malignancies
A Phase 2 study testing Online, adaptive MR-guided SBRT, Online, non-adaptive MR-guided SBRT and European Organization for Research and Treatment of Cancer (EORTC) QLQ-30 in people with Pancreatic Cancer and Pancreas Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Pancreas Cancer, Cancer of the Pancreas
- What is being tested?
- Online, adaptive MR-guided SBRT, Online, non-adaptive MR-guided SBRT and European Organization for Research and Treatment of Cancer (EORTC) QLQ-30
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2017to 19 Mar 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Randomized Controlled Phase II Study of 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.
- Being tested
- Online, adaptive MR-guided SBRT, Online, non-adaptive MR-guided SBRT, European Organization for Research and Treatment of Cancer (EORTC) QLQ-30
- Medical subject headings
- Pancreatic Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online, adaptive MR-guided SBRTDevice
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
Online, non-adaptive MR-guided SBRTDevice
Patients will not have online-adaptive treatment planning
European Organization for Research and Treatment of Cancer (EORTC) QLQ-30Other
Also called EORTC QLQ-30
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Online, non-adaptive MR-guided SBRT; Other: European Organization for Research and Treatment of Cancer (EORTC) QLQ-30 |
| 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 Receives: Device: Online, adaptive MR-guided SBRT; Other: European Organization for Research and Treatment of Cancer (EORTC) QLQ-30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up through 6 months post-treatment (approximately 6 months and 2 weeks)
Secondary outcomes (6)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-treatment, six-weeks post treatment, and six months post-treatment
Number of Participants With Local Failure
Measured: At six month follow-up (approximately 6 months and 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study start19 Jan 2017
- Primary completion19 Mar 2018
- Study completion19 Mar 2018
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael C Roach, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950025
- Sponsor's protocol ID
- 201611018
- Status last verified
- Mar 2019
- First submitted
- 27 Oct 2016
- Last updated
- 3 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Phase II Study of Daily Online Adaptation Versus Localization for MRI-Guided SBRT for Unresectable Primary or Oligometastatic Abdominal Malignancies
- ClinicalTrials.gov ID
- NCT02950025
- Acronym / sponsor ID
- 201611018
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 19 Jan 2017 (actual)
- Primary completion
- 19 Mar 2018 (actual)
- Study completion
- 19 Mar 2018 (actual)
- First posted
- 31 Oct 2016 (estimated)
- Results
- Posted 20 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online non-adaptive MRI-guided SBRT | Active comparator | 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 * Quality of life questionnaire baseline, 6 weeks after treatment conclusion, and 6 months after treatment conclusion |
| Arm B: Online-Adaptive MRI-guided SBRT | Experimental | Device: Online, 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online, adaptive MR-guided SBRTPatients 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 | Device | Arm B: Online-Adaptive MRI-guided SBRT |
| Online, non-adaptive MR-guided SBRTPatients will not have online-adaptive treatment planning | Device | Online non-adaptive MRI-guided SBRT |
| European Organization for Research and Treatment of Cancer (EORTC) QLQ-30Also: EORTC QLQ-30* 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 | Other | Arm B: Online-Adaptive MRI-guided SBRT, Online non-adaptive MRI-guided SBRT |
Primary outcome
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
Time frame: Up through 6 months post-treatment (approximately 6 months and 2 weeks)
* 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.
6 secondary outcomes
Tumor Response Rate
Time frame: At six month follow-up (approximately 6 months and 2 weeks)
Progression-free Survival (PFS) Rate
Time frame: At six month follow-up (approximately 6 months and 2 weeks)-up
Disease Free Survival Rate
Time frame: At six month follow-up (approximately 6 months and 2 weeks)
Overall Survival (OS) Rate
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
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael C Roach, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Online, adaptive MR-guided SBRT, Online, non-adaptive MR-guided SBRT and European Organization for Research and Treatment of Cancer (EORTC) QLQ-30 in people with Pancreatic Cancer and Pancreas Cancer, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Up through 6 months post-treatment (approximately 6 months and 2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2019.