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Adaptive Radiation for Locally Advanced Rectal Adenocarcinoma

NCT05108428 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-04-01

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Viewray Inc.

    collaborator INDUSTRY

  • Natera, Inc.

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Jessica M Frakes, MD · Moffitt Cancer Center

  • Seth Felder, MD · Moffitt Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-23
Primary Completion
2023-10-09
Completion
2026-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05108428 on ClinicalTrials.gov