Hypoxia Imaging for Esophageal Cancer to Guide Personalized Radiation Therapy
Status:
Suspended
Trial end date:
2026-08-01
Target enrollment:
Participant gender:
Summary
This is a Phase I trial evaluating the safety of personalized radiation therapy based on
levels of hypoxia identified on FMISO-PET and MRI. All patients will receive a baseline FMISO
PET and MRI to identify levels of hypoxia. Patients with tumor hypoxia will receive a higher
dose of radiation therapy. Subjects who do not have hypoxic tumors will be treated with the
standard-of-care radiation regimen. After fraction 10 of radiation therapy, an additional MRI
will be performed. If this interim MRI demonstrates little or no response (as defined in
Section 6), an optional boost radiation dose can be administered.
Trial enrollment will be conducted in two parts. In Part 1, eight patients will be enrolled.
After all eight patients have completed the 30 day DLT period, enrollment will be placed on
hold and safety will be evaluated. During the interim analysis, one additional patient will
be allowed to be enrolled in the trial. If the trial meets stopping rules as described in
Section 11.3, the trial will be re-evaluated by the DSMC and the Principal Investigator.
However, if the rate of DLTs remains below the unacceptable toxicity rate, enrollment will
open to the enrollment of eight more patients.