Adaptive Radiation for Abdominopelvic Metastases
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorFox Chase Cancer Center
About this trial
Single arm Phase I trial of adaptive stereotactic body radiation (SBRT) for abdominopelvic metastases. Adaptive SBRT will allow for escalation of the prescription dose and target coverage while maintaining grade 3+ toxicity no greater than 10%. Subjects with metastatic cancer to the abdomen or pelvis requiring local control or palliation will be enrolled.
Eligibility criteria
Qualifiers
Subjects must have histologically or cytologically confirmed cancer that is metastatic (all solid tumor types accepted), with at least one target lesion untreated by radiation, IR techniques, or growing in the abdomen or pelvis. Adjacent lymph nodes in the same region (5 cm or closer) constitute one active lesion. Target lesion must be measurable according to RECIST v 1.1. Previous systemic therapies are allowed.
Age > 18 years.
ECOG performance status 0 or 1
Estimated survival of >/= 12 months
Disqualifiers
Subjects must not be experiencing toxicity due to prior therapy that has not resolved to ≤Grade 1 by study registration, with the exception of sensory neuropathy related to previous systemic therapy exposure, alopecia and fatigue.
Subjects must not be receiving any other investigational agents.
Subjects must not have known peritoneal carcinomatosis visible on imaging.
Subjects must not have known active solid tumors on imaging outside of abdomen/pelvis noted on screening imaging
Trial design
Treatments tested in this trial
- Adaptive Stereotactic Body Radiation
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov