Radiation and chemo may spare rectal cancer patients from surgery
NCT ID NCT02438839
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether a combination of radiation and chemotherapy can cure low rectal cancer, allowing patients to avoid surgery. About 108 people with early-stage rectal tumors near the anus will receive this treatment. The main goal is to see if the cancer stays under control in the pelvis two years after treatment ends.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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108 people
The number who actually took part.
- Started
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Sep 2015
- Expected to finish
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Dec 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.
Who is studied
Patients with low rectal cancer (tumor located ≤ 6 cm from the anal verge) who are referred to the participating departments and who fulfill the inclusion criteria.
- 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: * Histopathologically verified adenocarcinoma of the rectum * Planned abdominoperineal resection (APR) or ultralow resection * Primary, resectable T1-T3, N0 tumor. N1 nodal disease is acceptable, if the positive lymph nodes are localized to the mesorectum at the level of the tumor. * Distance from anal verge to lower edge of tumor ≤ 6 cm measured by rigid rectoscope * Performance status 0-2 * Patient acceptance to collection of biopsies and blood samples for translational research * Age ≥ 18 years * Normal function of bone marrow as evaluated by * neutrophils ≥ 1.5 x 10\^9/l * thrombocytes ≥ 100 * Normal function of liver * alanine aminotransferase (ALAT) \< 2.5 x upper limit of normal * bilirubin \< 2.5 x upper limit of normal * Kidney function \- Serum creatinine \< 1.5 x upper limit of normal or measured glomerular filtration rate (GFR) \> 30 ml/min * Fertile women must present a negative pregnancy test and use secure contraceptives during and 3 months after treatment. * Written and orally informed consent Exclusion Criteria: * Previous surgical treatment of the present cancer, including transanal excision of tumor. * Other malignant disease within the past five years except basocellular skin cancer and carcinoma in situ cervicis uteri * Distant metastases verified by imaging or biopsy * Previous radiation treatment of the pelvis * Pregnant or breastfeeding women
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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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Department of Oncology, Aalborg University Hospital
Aalborg, Denmark
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Department of Oncology, Rigshospitalet
Copenhagen, Denmark
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Department of Oncology, Vejle Hospital
Vejle, Denmark
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Department of Surgery, Aalborg University Hospital
Aalborg, Denmark
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Department of Surgery, Vejle Hospital
Vejle, Denmark
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