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Radiation and chemo may spare rectal cancer patients from surgery

NCT ID NCT02438839

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 This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 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.

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.

Participants

108 people

The number who actually took part.

Started

Sep 2015

Expected to finish

Dec 2026

An estimate. End dates often move.

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.

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

18 years and older

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: * 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

  • Department of Oncology, Aalborg University Hospital

    Aalborg, Denmark

  • Department of Oncology, Rigshospitalet

    Copenhagen, Denmark

  • Department of Oncology, Vejle Hospital

    Vejle, Denmark

  • Department of Surgery, Aalborg University Hospital

    Aalborg, Denmark

  • Department of Surgery, Vejle Hospital

    Vejle, Denmark

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