Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New radiation technique aims to spare rectal cancer patients from surgery

NCT ID NCT04808323

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tests whether MRI-guided adaptive radiation therapy, combined with the chemotherapy drug capecitabine, can safely treat rectal cancer while preserving the rectum. About 22 adults with stage I-III rectal cancer will receive escalating doses of radiation guided by real-time MRI. The main goal is to check for serious side effects, but researchers will also see if the cancer disappears completely.

What this could mean

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

Active substance
Capecitabine (chemotherapy) plus MRI-guided adaptive radiation therapy
What this could lead to
If successful, this approach could allow some rectal cancer patients to avoid surgery and keep their rectum, improving quality of life.
What could go wrong
This is a very early Phase 1 trial with only 22 people, focused on safety. It is too small to prove effectiveness, and there is a risk of serious side effects from the high radiation doses.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 22 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2021

Expected to finish

Jan 2029

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: 1. Age ≥ 18. 2. Pathologically confirmed (histologic or cytological), adenocarcinoma of the rectum. 3. Determined on staging evaluation to be clinical stage I, II or III. 4. No concerning unequivocal or biopsy-proven metastatic disease. Patients are eligible with either no evidence of distant metastatic disease, or "equivocal" evidence of distant metastatic disease, as judged by the multidisciplinary tumor board. This "equivocal" definition can include small lung or liver lesions that are not able to be radiographically characterized otherwise. 5. Eastern Cooperative Oncology Group (ECOG) status 0-2 within 45 days of study entry. 6. History/physical examination, including collection of weight and vital signs within 45 days prior to start of treatment. 7. MR of the rectum is mandatory for staging and follow-up. 8. Chest CT scan within 45 days prior to study entry. 9. Radiation treatment planning abdominal CT. A mandatory pelvic MR will be done as a simulation (SIM) (ideally with interpretation). The CT SIM will not be done with interpretation. Ability to undergo abdominal MR scans for staging and radiation planning and follow-up is mandatory. 10. Laboratory values (CBC, Chem24) 45 days prior to treatment as follows: 1. Carcinoembryonic antigen (CEA) (any value). 2. Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3. 3. Platelets ≥50,000 cells/mm3. 4. Hemoglobin ≥ 8.0 g/dl. (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.) 5. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 4 x upper limit of normal. 6. Total bilirubin \< 2 x upper normal mg/dL. 7. Alkaline phosphatase \< 4 x upper limit of normal. 11. Not on hemodialysis. 12. Ability to swallow oral medications. 13. Patients must be determined by medical oncology to be a candidate for systemic chemotherapy. 14. Patients must provide study-specific informed consent prior to study entry. 15. Negative serum pregnancy test (if applicable). 16. Women of childbearing potential and male participants who are sexually active must practice adequate contraception. Exclusion Criteria: 1. Biopsy-proven distant metastatic disease or high clinical concern for metastatic disease and tumor conference consensus of stage IV disease. 2. Prior invasive malignancy (except nonmelanomatous skin cancer, noninvasive breast cancer (DCIS), or prostate cancer under active surveillance). Other malignancies are allowed if patient has been disease free for a minimum of three years 3. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields. 4. Any major surgery within 28 days prior to study entry, except colonic stent placement, intestinal diversion without resection or vascular access insertion. 5. Severe, active comorbidity, defined as follows: 1. Unstable angina and/or congestive heart failure requiring hospitalization within the last six months. 2. Transmural myocardial infarction within three months prior to study entry. 3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration. 4. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration. 5. Uncontrolled malabsorption syndrome significantly affecting gastrointestinal function. 6. Any unresolved intestinal obstruction. 7. Acquired immune deficiency syndrome (AIDS), based upon current Centers for Disease Control and Prevention (CDC) definition. Note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because patients receiving antiretroviral therapy may experience possible pharmacokinetic interactions with required treatment medications, such as capecitabine. 8. Absence of any significant medical comorbidity which would preclude the consideration of major intestinal surgery. 6. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception during the course of the study and for women three months after study therapy is completed and for men six months after study therapy is completed. This exclusion is necessary because the treatment involved in this study may be significantly teratogenic. 7. Participation in another interventional clinical treatment trial while on study (observational trials are permitted). 8. Patients taking nonprotocol-specified chemotherapy agents or immune-modulating agents for other medical conditions are not permitted to participate in this trial. Any medication questions should be reviewed by the PI. 9. Poor functional status such that patients are not able to be positioned for radiation treatments. 10. Gadolium allergy. 11. If age over 60, history of hypertension, diabetes or liver transplant, and glomerular filtration rate (GFR) at enrollment is \< 30.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Rectal adenocarcinoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Froedtert & the Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

More trials for these conditions

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