Ultra-fractionated Radiotherapy for Rectal Cancer

This study is testing a new way to treat locally advanced rectal cancer using a special type of radiation called ultrafractionated radiotherapy. This radiation is given over a longer period at higher doses, combined with chemotherapy drugs like FOLFOX or CAPOX. The goal is to see if this approach can improve how well the treatment works and potentially allow some patients to avoid surgery. Researchers are looking for the highest dose of radiation that can be given safely. You may be able to join if you are at least 18 years old, have a specific type of rectal cancer (T3-4 and/or N+ disease), and have not had prior treatment for it. The main success measure for this study is to find the highest safe dose of radiation within 60 days after treatment. The current status of this study is unclear.

Study design: This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 27 participants.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: The primary endpoint is measured at 0 to 60 days post radiation therapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Ultra-fractionated Radiotherapy for Rectal Cancer

Active, Not Recruiting

PHASE1Ages 18+InterventionalTreatment

University of Texas Southwestern Medical Center

~27 participants

Updated 2026-07-24 on ClinicalTrials.gov

What's tested:Ultrafractionated radiotherapy for rectal cancer

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

To determine the maximal tolerated dose (MTD) of dose-escalated hypofractionated RT.

Measured over 0 to 60 days post radiation therapy

Conditions

Rectal Cancer

Where it's being run

1 sites across 1 states

Texas1

Study leadership

Nina Sanford, MD · PRINCIPAL_INVESTIGATOR · UT SOUTHWESTERN medical CENTRE

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

WBC ≥ 3,000/mL;

ANC WBC ≥ 1,000/mL;

PLT ≥ 75,000/mL;

T Bili ≤ 1.5 x upper limit of normal (ULN);

AST/ALT ≤ 2.5 x ULN;

Creatinine not above ULN, or creatinine clearance \>50 mL/min/1.73 m\^2 for participants with creatinine levels above institutional normal. 8. All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) starting with the first dose of study therapy through 90 days after the last dose of study drugs. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

Has not undergone a hysterectomy or bilateral oophorectomy; or

Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

What this trial measures

To determine the maximal tolerated dose (MTD) of dose-escalated hypofractionated RT.0 to 60 days post radiation therapy
The MTD will be based upon toxicity, which will be assessed according to the NCI's CTCAE v5.0 toxicity criteria. Dose limiting toxicities will include any of the following Grade 3+ GI toxicities.

Trialytics