Rectal cancer patients may skip surgery with chemo and watchful waiting
NCT ID NCT03594630
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial is testing whether people with stage II-III rectal cancer can safely avoid surgery by first receiving chemotherapy and then being closely monitored. The goal is to see if the rectum can be preserved without harming survival. Around 120 participants will be followed to measure how many remain surgery-free after one year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- chemotherapy
- What this could lead to
- If successful, this approach could allow many patients with rectal cancer to avoid major surgery and keep their rectum.
- What could go wrong
- This is a very early pilot study with only 120 participants. It is not yet known if deferring surgery is safe, and there is a risk of tumor regrowth.
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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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Oct 2026
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: * Histologically confirmed diagnosis of rectal adenocarcinoma * Eligible for curative resection of rectal adenocarcinoma * Rectal tumor location =\< 12 cm from the anal verge as determined by endoscopy or magnetic resonance imaging (MRI) (if endoscopy report is not available or deemed inadequate my treating oncologist) * Nodal involvement confined to the radiation field * Radiologically measurable or clinically evaluable disease as defined in the protocol * Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0, 1 or 2 * Clinical Stage: Stage II and III. N2 disease is to be estimated as four or more lymph nodes that are \>= 10 mm. Clinical staging should be estimated based on the combination of the following assessments: physical exam by the primary surgeon including digital rectal exam (DRE), computed tomography (CT) or positron emission tomography (PET)/CT scan of the chest/abdomen/pelvis and a pelvic MRI. If a pelvic MRI is performed, it is acceptable to perform CT of the chest/abdomen, omitting CT imaging of the pelvis. PET/CT is optional. * No known contraindication to standard (fluoropyrimidine-based) pelvic chemoradiation (e.g. dihydropyrimidine dehydrogenase \[DPD\] deficiency) * Patient of child-bearing potential is willing to employ adequate contraception during treatment and after treatment, as directed by treating clinical team * Willing to provide written informed consent * Willing to return to enrolling medical site for all study assessments Exclusion Criteria: * Diagnosis of inflammatory bowel disease (IBD) * Diagnosis of MSI-H colorectal cancer at time of consent * Recurrent rectal cancer * Tumor is causing symptomatic bowel obstruction (patients who have diverting ostomy are eligible) * Any prior pelvic radiation * Other invasive malignancy undergoing active treatment. Patients receiving prior treatment that precludes standard chemoradiation or ability to receive consolidation/adjuvant chemotherapy will be excluded from survival analyses * Patients unwilling or unable to undergo pelvic MRI
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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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M D Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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