NCT04621370 - A Trial of Durvalumab (MEDI 4736) in Combination With Extended Neoadjuvant Regimens in Rectal Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

December 7, 2020

Primary Completion Date

June 30, 2025

Study Completion Date

December 31, 2025

Conditions

Rectal CancerRectal AdenocarcinomaRectal Neoplasms

Interventions

DRUG

Durvalumab

Flat dose of 1500mg delivered intravenously over 30 minutes every 4 weeks.

DRUG

FOLFOX

"Oxaliplatin 85mg/m2 delivered intravenously as per institutional standard on Day 1 of mFOLFOX6 treatment every 2 weeks.~5-fluorouracil bolus 400mg/m2 delivered intravenously as per institutional standard on D1 of mFOLFOX6 treatment every 2 weeks.~5-fluorouracil infusion 2400mg/m2 delivered intravenously over 46 hours continuously as per institutional standard following bolus 5-fluorouracil."

RADIATION

Short Course Radiotherapy (Arm A)

25 Gray of photon radiation treatment delivered over 5 fractions.

RADIATION

Long course chemoradiation (Arm B)

50 Gray of photon radiation treatment delivered over 25 fractions.

DRUG

Capecitabine

Capecitabine is a non-cytotoxic pre-cursor of cytotoxic 5-fluorouracil and delivered in oral form. It is given concomitantly with long course radiation treatment on days of radiotherapy only. The dose is 825mg/m2 and this is delivered twice daily.