NCT05108428

Adaptive Radiation for Locally Advanced Rectal Adenocarcinoma

MRI Guided Adaptive Radiation for Locally Advanced Rectal Adenocarcinoma to Enhance Complete Response

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine the feasibility of using magnetic resonance imaging (MRI)-guided adaptive chemoradiation therapy to improve response to treatment.

Conditions

• Rectal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Capecitabine	Capecitabine 825 mg/m\^2 twice daily orally 5 days per week on days of planned radiation therapy.
RADIATION	Radiation Therapy	Participants will receive varying doses of radiotherapy based on MRI guidance, beginning at 28-33 fractions (1.8 Gray units) .
DRUG	FOLFOX regimen	Standard of Care FOLFOX regimen consists of 8 cycles (each cycle is 14 days) of 5-fluorouracil, leucovorin, and oxaliplatin. Dosage is as follows: Oxaliplatin 85 mg/m\^2 IV over 2 hours day 1 each cycle. Leucovorin (optional) 400 mg/m\^2 IV over 2 hours day 1 each cycle. 5-fluorouracil bolus\* (optional) 400 mg/m\^2 IV push day 1 of each cycle, and 5-fluorouracil infusion 2400 mg/m\^2 IV continuous infusion over 46 hours day 1 each cycle.

Timeline

• Start date: 2021-12-23
• Primary completion: 2023-10-09
• Completion: 2026-10-01
• First posted: 2021-11-05
• Last updated: 2026-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study