22
Participants
Start Date
June 17, 2021
Primary Completion Date
April 14, 2027
Study Completion Date
January 20, 2029
Capecitabine
825 mg/m\^2 twice daily during radiation therapy. (Fluorouracil (5-FU) may be used at the discretion of the treating medical oncologists.) This chemotherapy will be given during the initial radiation dose (50 Gy over 25 frac) and continue for Cohorts A, B, and C.
Initial Dose of Radiation before Dose Escalation
50 Gy over 25 frac.
Cohort A: Dose Escalation Radiation
Cohort A will receive 14 Gy boost for a total of 64 Gy over 32 total fractions.
Cohort B: Dose Escalation Radiation
Cohort B will receive 18 Gy boost for a total of 68 Gy over 34 total fractions.
Cohort C: Dose Escalation Radiation
Cohort C will receive 22 Gy boost for a total of 72 Gy over 36 total fractions.
FOLFOX
After the completion of radiation, subjects will receive up to eight cycles of systemic chemotherapy. (FOLFIRINOX may be used at the discretion of the treating medical oncologists.)
RECRUITING
Froedtert & the Medical College of Wisconsin, Milwaukee
Medical College of Wisconsin
OTHER