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MRI-Guided Adaptive Radiation Therapy for Organ Preservation in Rectal Cancer

NCT04808323 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2026-03-16

No results posted yet for this study

Summary

This study is a prospective, open-label, phase I design.

Conditions

  • Rectal Adenocarcinoma

Interventions

DRUG

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.

DEVICE

Initial Dose of Radiation before Dose Escalation

50 Gy over 25 frac.

DEVICE

Cohort A: Dose Escalation Radiation

Cohort A will receive 14 Gy boost for a total of 64 Gy over 32 total fractions.

DEVICE

Cohort B: Dose Escalation Radiation

Cohort B will receive 18 Gy boost for a total of 68 Gy over 34 total fractions.

DEVICE

Cohort C: Dose Escalation Radiation

Cohort C will receive 22 Gy boost for a total of 72 Gy over 36 total fractions.

DRUG

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.)

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • William Hall, MD · Medical College of Wisconsin

  • Carrie Peterson, MD · Medical College of Wisconsin

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-17
Primary Completion
2027-04-14
Completion
2029-01-20
FDA Drug
Yes
FDA Device
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 NCT04808323 on ClinicalTrials.gov