OAR-Based, Dose Escalated SBRT With Real Time Adaptive MRI Guidance for Liver Metastases
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|ClinicalTrials.gov Identifier: NCT04020276|
Recruitment Status : Recruiting
First Posted : July 16, 2019
Last Update Posted : May 11, 2021
Stereotactic Body Radiation Therapy (SBRT) is a noninvasive local therapy with proven efficacy in a number of solid tumor types. However, colorectal cancer (CRC) liver metastases have been shown to be particularly resistant to SBRT, and often are found to have significantly worse rates of control compared with other histologies. Higher SBRT dose was recently shown to improve local control in CRC pulmonary metastases, however, increasing dose delivery with SBRT has been limited based on the risk of toxicity to adjacent structures, and the ability to visualize them during treatment. This is particularly relevant in treating liver tumors, as tumor and small bowel movement can often make tumor targeting and organs-at-risk (OAR) avoidance especially difficult. MRI-guided SBRT for liver tumors is both safe and feasible and offers an as yet unprecedented opportunity to achieve the highest possible safe dose to liver tumors.
The purpose of this trial is to identify a safe maximum tolerated dose level for MRI-guided SBRT treatment of bowel and liver metastases, respectively.
Eligible participants will be on study for up to 12 months.
|Condition or disease||Intervention/treatment||Phase|
|Liver Metastases Stereotactic Body Radiation Therapy MRI-guided Treatment||Radiation: SBRT||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
Phase IA: 4+4 dose-escalation design - patients will be treated to a maximum tolerated dose using MRI-guided SBRT with real time adaptation.
Phase IB: Confirmatory expansion cohort in patients with liver metastases from colorectal cancer.
|Masking:||None (Open Label)|
|Official Title:||A Phase IA/IB Study of OAR-Based, Dose Escalated SBRT With Real Time Adaptive MRI Guidance for Liver Metastases|
|Actual Study Start Date :||November 4, 2019|
|Estimated Primary Completion Date :||August 2023|
|Estimated Study Completion Date :||August 2023|
Experimental: MRI-Guided SBRT Dose Escalation
Treatment on MRI Linac with SBRT in 5 fractions with adaptive planning, maximum dose 80 Gy
Dose Escalation Bowel Pathway, V34 < 0.5cc Dose Escalation Liver Pathway, 700 cc < 16 Gy
Subsequent Phase 1B: CRC only for Safety and Local Control, dosage informed by Phase 1A
Participants will receive 5 fractions of radiation, which will be delivered 2-3 times per week. SBRT should be complete in a 1.5 to 2 week time frame. There should be a minimum of 12 hours between treatments. Each fraction will be escalated or de-escalated to meet the overall constraints in phase IA or both previously identified constraints in phase IB
- Number of Participants with Acute Dose Limiting Toxicity (DLT) [ Time Frame: Up to 4 weeks ]
Dose limiting toxicity (DLT) will be defined as grade 3 or greater* non-hematologic toxicity attributable to radiation therapy, and occurring within 4 weeks after the completion of SBRT.
*With the exception of liver function tests, which are allowed up to and including grade 3
- Progression Free Survival (PFS) [ Time Frame: Up to 5 years ]Progression-free survival (PFS) will be defined as the difference (in months) between the date of study enrollment and the date of disease progression or death due to any cause
- Overall Survival (OS) [ Time Frame: Up to 5 years ]Overall survival (OS) will be defined as the difference (in months) between the date of study enrollment to the date death due to any cause.
- Local Control Rates [ Time Frame: up to 1 year ]Point estimates along with the exact 95% confidence interval will be computed for the local control rates
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04020276
|Contact: Cancer Connectfirstname.lastname@example.org|
|United States, Wisconsin|
|University of Wisconsin||Recruiting|
|Madison, Wisconsin, United States, 53792|
|Contact: Cancer Connect 800-622-8922 email@example.com|
|Principal Investigator:||Michael Bassetti, MD, PhD||University of Wisconsin, Madison|