Trial of Oligometastasis SBRT With Immediate, Simulation-Free Treatment Delivery (OLIGO-SWIFT)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCase Comprehensive Cancer Center
About this trial
This study is for participants whose cancer is oligometastatic, meaning it has spread to up to five spots in their body and their doctor recommends that they have stereotactic body radiation therapy (SBRT) to treat these cancer sites. SBRT is a type of radiation therapy that may help people with oligometastatic disease live longer without cancer progression. SBRT is usually given in addition to other cancer treatments, like chemotherapy, immunotherapy, or hormone therapy.
Preparing for SBRT can take up to a week or longer. This can make it harder for participants to receive SBRT and coordinate care. This can also mean a longer time until symptoms from cancer sites improve. Doctors would like to treat oligometastatic cancers more quickly by reducing the time it takes to plan for the SBRT.
The typical workflow for SBRT includes doctors doing a simulation which requires a CT (Computerized Tomography) scan. The CT scan is used to create a treatment plan. It can take time to schedule this CT scan and then it normally takes another 5-10 days to create a treatment plan.
A way to reduce the planning time for SBRT is to use the CT scan (or other radiology scan types, like magnetic resonance imaging \[MRI\] or positron emission tomography \[PET\]) that participants had when their cancer was diagnosed to plan their SBRT. This eliminates the scheduling of an additional CT scan and the 5-10 day planning time. This is called CTsim-free (CT simulation-free) treatment planning.
CT-sim-free radiation therapy planning has been shown to be effective in treating cancers that are causing pain in people with more advanced or widespread cancers. This study is being done to find out if it is safe and effective to use CTsim-free planning for SBRT to treat oligometastases.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must have histologically, cytologically, or radiographically or confirmed cancer that is oligometastastatic (defined in this protocol as up to 5 active sites of disease at time of trial enrollment). Note that previous ablative therapy to the treatment site (excluding prior external beam radiation) is permitted, such as previous microwave ablation or radiofrequency ablation.
Age ≥18 years.
Performance status: Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2
Estimated life expectancy of at least 3 months
Disqualifiers
Prior radiotherapy to any site overlapping with the projected site for protocol treatment.
Participants with isolated vertebral metastases except for sacral spine; participants with osseous spine disease can be treated upon this protocol, but those sites (cervical, thoracic, lumbar spine) are not permitted for treatment upon this study. Such participants could be enrolled for treatment to other, concurrent (e.g., visceral, or non-spine bone) disease on this study.
Pregnant or breastfeeding women are excluded from this study.
Women of childbearing potential must have a negative pregnancy test within 14 days of study entry. If pregnancy test is not clinically indicated as determined by the treating physician or protocol principal investigator (PI), documentation of this exception is sufficient in lieu of a pregnancy test.
Trial design
Design model
Single group
Treatments tested in this trial
Simulation-free workflow
Other interventionPre-existing diagnostic images (CTs, PET/CTs, or MRIs) will be imported into the online treatment planning system called Ethos. The Ethos platform and online adaptive radiation therapy (ART) will be utilized at the time of treatment planning and the first (of five) fractions. Subsequent fractions will be delivered using standard image-guided radiotherapy (IGRT) or ART; this will be decided by the treating physician and institutional guidelines.
SBRT
RadiationParticipants will receive SBRT per standard of care in up to five fractions. Fractions will be delivered once daily or once every other day over a total period of one to two weeks.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Simulation-free treatment delivery of SBRTExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Feasibility of a simulation-free adaptive radiotherapy approach for oligometastasis SBRT in clinical settings, as measured by successful completion of treatment
Successful completion of treatment will be determined by first-fraction radiation delivery occurring in the first on-table treatment attempt for at least 70% of participants with simulation-free plans meeting dosimetric requirements.
Time frame
Up to 2 weeks (timeframe of SBRT treatment)2
Feasibility of a simulation-free adaptive radiotherapy approach for oligometastasis SBRT in clinical settings, as measured by pre-treatment quality assurance clinical gamma passing index
A pre-treatment quality assurance clinical gamma passing index that is less than or equal to 2%/2mm will be considered successful.
Time frame
Up to 2 weeks (timeframe of SBRT treatment)Sponsors and contacts
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Source ClinicalTrials.gov