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Rearranging the treatment timeline: could a new sequence of chemo and radiation spare rectal cancer patients from major surgery?

NCT ID NCT03941366

Disease control Sponsor: Henry Ford Health System Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This trial is testing whether giving chemotherapy before the standard combination of chemo and radiation for rectal cancer could allow some patients to have a minor surgical procedure instead of a major one. The study enrolls adults with stage T2-T3 rectal cancer. The goal is to see if this new timing can reduce the need for extensive surgery and improve quality of life without compromising cancer control.

What this could mean

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

Active substance
a modified schedule of chemotherapy (FOLFOX and 5FU/capecitabine) and radiation, followed by local excision instead of major surgery
What this could lead to
If successful, this approach could allow many rectal cancer patients to avoid major surgery and its side effects, potentially improving quality of life while controlling the disease.
What could go wrong
This is a very small, early-phase trial with only 15 participants, so results may not apply broadly. There is also a risk that less extensive surgery might not remove all cancer cells, leading to recurrence.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

15 people

The number who actually took part.

Started

Feb 2016

Finished

Apr 2025

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 to 95 years

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 years 2. Diagnosis of rectal invasive adenocarcinoma 3. Tumor in the low or mid rectum (up to 11 cm from the anal verge) 4. Clinical stage T3/N0-N1M0. Patients with low T2 who will need abdominal perineal resection are also eligible. 1\. Clinical staging will be estimated based on the combination of the following assessments: 1. Physical examination by the primary surgeon 2. Computed Tomography or Positron Emission Tomography/Computed Tomography scan of chest, abdomen and pelvis 3. Pelvic MRI and endoscopic ultrasound Exclusion Criteria: * Less than 18 years of age * Do not complete informed consent * Pregnant women

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Conditions

The condition(s) this trial relates to.

rectal cancer rectal neoplasm rectum adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rectal cancer

Contacts and locations

Locations

  • Ascension St. John Hospital

    Detroit, Michigan, 48236, United States

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