New radiation combo may let some rectal cancer patients skip surgery
NCT ID NCT04677413
First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 1 time
Summary
This early-phase trial is testing a new way of giving radiation therapy (ultra-fractionated, short course) along with standard chemotherapy for people with locally advanced rectal cancer. The goal is to see if this combination can shrink the tumor enough to avoid surgery. The study will enroll 27 adults with stage T3-4 or node-positive rectal cancer who have not had prior treatment. The main focus is on safety and finding the highest dose that does not cause severe side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ultra-fractionated radiotherapy with FOLFOX or CAPOX chemotherapy
- What this could lead to
- If successful, this approach could allow some patients with advanced rectal cancer to avoid surgery by achieving a complete response with radiation and chemo alone.
- What could go wrong
- This is a very early phase 1 trial with only 27 participants, focused on safety and finding the right dose. It is not yet known if it will be effective or widely applicable, and there is a risk of serious gastrointestinal side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 27 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2021
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. At least 18 years of age. Both men and women and members of all races and ethnic groups will be included. 2. Willing and able to provide written informed consent 3. Pathologic diagnosis of rectal adenocarcinoma 4. T3-4 and/or N+ disease per AJCC 8th edition 5. No prior treatment for rectal adenocarcinoma 6. Eastern Cooperative Group (ECOG) performance status of 0-2. 7. Laboratory values supporting acceptable organ and marrow function within 30 days of eligibility confirmation. Defined as follows: * 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. A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * 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). Exclusion Criteria: 1. Distant nodal disease (retroperitoneal nodes) including inguinal nodes, or any metastatic disease by CT. 2. Prior RT to the pelvis. 3. Uncontrolled comorbid illness or condition including congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness that would limit compliance with the study requirements. 4. Psychiatric illness/social situations that would limit consenting and compliance with study requirements. 5. Participants who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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UT Southwestern Medical Center
Dallas, Texas, 75390-8849, United States
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