Can early rectal cancer be treated without removing the rectum?
NCT ID NCT02945566
First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time
Summary
This trial investigates whether less invasive treatments can save the rectum in people with early-stage rectal cancer. Participants receive either standard surgery (removing part of the rectum) or one of two organ-sparing approaches: short-course radiotherapy or chemoradiation (chemotherapy plus radiation), followed by close monitoring or a small local surgery. The goal is to see if these gentler options can control the cancer while avoiding a permanent stoma and reducing side effects.
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) and radiotherapy
- What this could lead to
- If successful, this could offer a way to treat early rectal cancer without removing the rectum, avoiding a permanent or temporary stoma and improving quality of life.
- What could go wrong
- This is an early-to-mid-stage trial, so the organ-sparing approach may not control the cancer as well as standard surgery, and some patients may still need a stoma or further treatment.
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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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 380 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2017
- Expected to finish
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Aug 2028
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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16 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: * Biopsy proven adenocarcinoma of the rectum * MRI-defined ≤T3b (with ≤5mm of mesorectal invasion) rectal tumour or endorectal ultrasound-defined ≤uT3b rectal cancer (optional: in centres where high quality endorectal ultrasound (ERUS) is available or patient unable to tolerate MRI) * MDT determines that all of the following treatment options are reasonable and feasible: --TME surgery, (b) CRT (c) SCRT d) TEM. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * For patients choosing organ preservation only: * If female and of childbearing potential, must: * Have a negative pregnancy test within 7 days prior to study entry * Agree to use adequate, medically approved, contraceptive precautions from trial entry until 6 months after the end of study treatment * If non-sterilised male male with a partner of childbearing potential, must: * Agree to use adequate, medically approved, contraceptive precautions from trial entry until 6 months after the end of study treatment * Patient able and willing to provide written informed consent for the study Exclusion Criteria: * Concomitant or previous malignancies within 3 years prior to trial entry, except those that in the opinion of the MDT are unlikely to relapse within 3 years or lead to death within 5 years * Unequivocal evidence of metastatic disease (includes resectable metastases) \-- Patients with equivocal radiological lesions (e.g. retroperitoneal, liver, lung) that are not classified as M1 are eligible if agreed by MDT * MRI node positive (≥N1, defined by protocol guidelines) \-- Patients with equivocal radiological findings that are either classified as NX or N0 are eligible * MRI extramural vascular invasion (mriEMVI) positive (defined by protocol guidelines) * MRI defined mucinous tumour * Mesorectal fascia threatened (≤1 mm on MRI or ERUS) * Maximum tumour diameter \> 40mm (either measured from everted edges on sagittal MRI or on ERUS) * Tumour position anterior, above the peritoneal reflection on MRI or EUS * No residual luminal tumour following endoscopic resection * Contraindications to radiotherapy including previous pelvic radiotherapy * Uncontrolled cardiorespiratory comorbidity (includes patients with inadequately controlled angina or myocardial infarction or arrhythmia within 6 months prior to trial entry) * Known complete dihydropyrimidine dehydrogenase (DPYD) deficiency * Known Gilbert's disease (hyperbilirubinaemia) * Taking coumarin-derivative anticoagulants (e.g. warfarin) that cannot be discontinued at least 7 days prior to starting treatment or substituted by low molecular weight heparin * Taking phenytoin or sorivudine or its chemically related anologues, such as brivudine, within 4 weeks of trial entry (see Section 8.3.5 for further details) * Taking metronidazole at study entry * Pregnant or lactating women * History of severe and unexpected reactions to fluoropyrimidine therapy * Age \<16 years (UK), \<18 years (other countries)
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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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Odense University Hospital
Odense, Denmark
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Radboud University medical center
Nijmegen, Netherlands
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Region Stockholm, Onkologkliniken Södersjukhuset AB
Stockholm, Sweden
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University Hospital UZ Leuven
Leuven, Belgium
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University of Birmingham
Birmingham, B15 2TT, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New drug cocktail aims to shrink rectal tumors before surgery
- New study aims to Fine-Tune radiation for liver cancer spread
- Shorter radiation may be just as good for rectal cancer patients
- Researchers track rectal cancer treatment responses