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Smart scans guide radiation to zap rectal cancer more precisely

NCT ID NCT05108428

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tests whether using MRI scans during radiation treatment can help doctors adjust the radiation dose to better target rectal cancer. Twenty people with stage II or III rectal cancer will receive standard chemotherapy plus MRI-guided radiation. The main goal is to see if this personalized approach is feasible and leads to complete tumor disappearance.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Capecitabine, FOLFOX regimen, and MRI-guided radiation therapy
What this could lead to
If successful, this approach could increase the chance of eliminating all detectable tumor after treatment, potentially reducing the need for more aggressive surgery.
What could go wrong
This is a very early, small trial (20 people) focused on feasibility, not proof of effectiveness. The approach may not improve outcomes and carries standard risks of chemoradiation like fatigue, nausea, and bowel issues.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

20 people

The number who actually took part.

Started

Dec 2021

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance status of 0, 1 * Histologically confirmed diagnosis of adenocarcinoma of the rectum. * Clinical Stage II or III as determined on rectal MRI with a distal tumor extent/margin no more than 1 cm proximal to the anterior peritoneal reflection. * Must have the ability to swallow and retain oral medications * Adequate hematologic function within 28 days before registration as defined in protocol. * Adequate hepatic function within 45 days before registration, as defined in protocol. * Adequate renal function within 28 days before registration, as defined in protocol. * International normalized ratio of prothrombin time (INR) and prothrombin time (PT) within 28 days before registration must be within normal limits for the lab. Patients who are therapeutically treated with an agent such as warfarin may participate if they are on a stable dose and no underlying abnormality in coagulation parameters exists per medical history * Pregnancy test done within 14 days before registration must be negative (for women of childbearing potential only). Pregnancy testing should be performed according to institutional standards. Exclusion Criteria: * Patients with one or more of the following conditions are NOT eligible for this study: * Rectal cancer histology other than adenocarcinoma (i.e., sarcoma, lymphoma, squamous cell carcinoma, mucosal melanoma, mixed adenoneuroendocrine, anal adenocarcinoma, etc.). * History of prior invasive rectal malignancy, regardless of disease-free interval or history of familial polyposis syndrome (Lynch, FAP, etc.). * Patients with a history of antineoplastic treatment for prior malignancy within the past 3 years, except for adequately treated basal cell skin carcinoma or in situ cervical cancer. Note: Hormone therapy for breast cancer is permitted. * Primary unresectable rectal cancer. Note: A tumor is considered unresectable when invading adjacent organs and an en bloc resection will not achieve negative margins. * Synchronous colorectal adenocarcinomas. * Tumor may not be causing symptomatic bowel obstruction * Definitive clinical or radiologic evidence of metastatic disease or nodal disease outside of the prescribed radiation field. Note: Required imaging studies must have been performed within 28 days prior to enrollment. * Patients with a history of an arterial thrombotic event within the past 6 months. This includes angina (stable or unstable), myocardial infarction, transient ischemic attack (TIA), Cardiovascular Accident (CVA). Note: Patients with a history of venous thrombotic episodes such as deep venous thrombosis, pulmonary embolus occurring more than 6 months prior to enrollment may be considered for protocol participation, provided they are on stable doses of anticoagulant therapy. Similarly, patients who are anticoagulated for atrial fibrillation or other conditions may participate, provided they are on stable doses of anticoagulant therapy. * No other experimental therapies (including chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, matric metalloprotease inhibitors, thalidomide, anti-VEGF (vascular endothelial growth factor) monoclonal antibody or other experimental drugs) of any kind are permitted while the patient is receiving study treatment. * Inflammatory bowel disease or have a history of abdominal surgery that may interfere with gastrointestinal motility or absorption. * Ineligibility to undergo MR imaging or treatment on the MRL due to medical or physical reasons. Anxiety disorders will be permitted if pre-medicated with anxiolytics. * Active seizure disorder uncontrolled by medication. * Major surgery within 12 weeks before enrollment. * Any prior pelvic radiation. * Known DPD (dihydro pyrimidine dehydrogenase) deficiency. Any of the following because this study involves agents that have known or potential genotoxic or mutagenic and teratogenic effects: Pregnant women, Nursing women who are unwilling to discontinue nursing, Men or women of childbearing potential who are unwilling to employ adequate contraception (e.g. hormonal or barrier method of birth control; abstinence) for the duration of study treatment and for 3 months after the last dose of study therapy. * Any diagnosis of acquired immunodeficiency syndrome (AIDS-related illnesses) or known human immunodeficiency virus (HIV) disease. * Co-morbid illnesses or other concurrent disease that, in the judgement of the clinician obtaining informed consent, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens or prevent required follow-up. * BMI \> 40 is considered exclusive from this study due to increased surgical complication risk and greater risk of incomplete resection

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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

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.