Can Higher-Dose radiation spare rectal cancer patients from surgery?
NCT ID NCT05412082
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial is testing whether giving chemotherapy first, followed by a higher-than-usual dose of MRI-guided radiation, can eliminate tumors in people with locally advanced rectal cancer. The goal is to see if this approach is safe and can lead to a complete response, potentially avoiding the need for surgery. The study involves 25 participants and focuses on tracking side effects and tumor response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 5-fluorouracil (5-FU) chemotherapy and intensity-modulated radiation therapy (IMRT)
- What this could lead to
- If successful, this approach could allow some patients with locally advanced rectal cancer to avoid surgery by achieving a complete response through higher-dose radiation and chemotherapy.
- What could go wrong
- This is a very early phase 1 trial with only 25 participants, so safety and effectiveness are not yet proven. Higher radiation doses may increase side effects, and not all patients will achieve a complete response.
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 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2022
- Expected to finish
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Oct 2028
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. Patients with newly diagnosed, biopsy proven, rectal adenocarcinoma. 2. Primary tumor located ≤18 cm from margin verge. 3. Primary tumor either a T3N0 or T1-4 N positive (as defined per pelvic MRI; nodes ≤ 15 mm). 4. ≥ 18 years of age. 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 6. Serum liver function tests values within the range of 1.5 x Upper Limit of Normal (within 6 weeks of enrollment). 7. Negative pregnancy test for women of child-bearing potential (within 4 weeks of enrollment). 8. Ability to understand and the willingness to sign a written informed consent document. 9. Patient is assessed by a surgeon, medical oncologist and a radiation oncologist and deemed fit for Total Neoadjuvant ChemoTherapy (TNT) and surgery. Exclusion Criteria: 1. Metastatic disease on initial work up (Chest and abdomen contrast enhanced CT scan). 2. Synchronous cancer found on colonoscopy. 3. Previous history of pelvic radiotherapy. 4. History of concurrent, active malignancy other than non-metastatic skin cancer within the last 2 years. 5. Symptomatic congestive heart failure of New York Heart Association Class III or IV, unstable angina pectoris or uncontrolled severe cardiac arrhythmia, myocardial infarction within the last 6 months. 6. Psychiatric illness/social situations that would limit compliance with study requirements. 7. Active (acute or chronic) or uncontrolled severe infections requiring intravenous antibiotics or active tuberculosis (TB). 8. Patients with poorly controlled acquired immune deficiency syndrome (AIDS) who are not deemed candidates for FOLFOX, mFOLFIRINOX or CAPOX chemotherapy. Active connective tissue disorders, such as lupus or scleroderma, that, in the opinion of the treating physician may put the patient at high risk for radiation toxicity. 9. Active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the treating physician may put the patient at high risk for radiation toxicity 10. Sensory or motor neuropathy ≥ grade 2. 11. Women who are breast feeding. 12. Exclusions due to MRI use in study: ferromagnetic metal in body/eye, pacemaker, defibrillator, other mechanical device, or extreme claustrophobia (medication with anti-anxiety agents, such as Ativan, may be attempted).
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Miami
RECRUITINGMiami, Florida, 33136, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a targeted radiation combo boost rectal cancer remission?
- Can a short burst of radiation plus triple chemotherapy wipe out rectal cancer before surgery?
- MRI-Guided radiation boosts hopes for rectal cancer patients