Rectal cancer: could a 'Watch and Wait' strategy spare patients from major surgery?
NCT ID NCT05526079
First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time
Summary
This trial is testing whether a 'watchful waiting' approach after chemotherapy and radiation can safely avoid radical surgery in people with a certain type of rectal cancer. Participants receive chemotherapy (FOLFOX) followed by chemo-radiation, and those whose tumors completely respond are closely monitored instead of undergoing immediate surgery. The goal is to see if this non-operative management can maintain cancer control and improve quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- neoadjuvant chemotherapy (FOLFOX) followed by chemo-radiotherapy (fluorouracil or capecitabine) and watchful waiting
- What this could lead to
- If successful, this approach could allow some rectal cancer patients to avoid major surgery and its complications while maintaining cancer control.
- What could go wrong
- This is a very small, early-phase trial. The watchful waiting strategy may lead to tumor regrowth, and long-term survival outcomes are uncertain.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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15 people
The number who actually took part.
- Started
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Jul 2018
- Finished
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Mar 2026
- 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 to 95 years
- 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. Age ≥ 18 years 2. Diagnosis of rectal invasive adenocarcinoma 3. Tumor in the low rectum lying \< 4 cm from the anal verge 4. Clinical stage T3/N0-N1M0. 5. Patients with low T2 who will need abdominal perineal resection are also eligible. Exclusion Criteria: 1. Age less than 18 years 2. Other forms of cancer 3. Tumors \>= 4 cm from the anal verge 4. Tumors of other clinical stages than listed above
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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
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Ascension St. John Hospital
Detroit, Michigan, 48236, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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