NCT02438839Active, not recruiting
Curative Chemoradiation of Low Rectal Cancer
Curative Chemoradiation of Low Rectal Cancer. A Prospective Multicenter Observational Study
Source: ClinicalTrials.gov · Last updated 8 Jan 2026
Brief summary (registry, in English)
The aim of the present study is to investigate whether curative chemoradiation of low rectal cancer is feasible, safe and effective in a multicenter study with results comparable to those of single center studies. Results from previous studies indicate that a considerable fraction of patients with low rectal cancer can be cured by a combination of radiation and chemotherapy alone and thus be spared from operation.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 108 (actual)
- First submitted
- 5 May 2015
- Start date
- 1 Sept 2015
- Primary completion date
- 17 Mar 2022
- Lead sponsor
- Vejle Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT02438839
What you commit to
- Study type: Observational
- Participants enrolled: 108
- From 1 Sept 2015 to the primary completion date, 17 Mar 2022
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous surgical treatment of the present cancer, including transanal excision of tumor.
- Previous radiation treatment of the pelvis
Other illness
- Other malignant disease within the past five years except basocellular skin cancer and carcinoma in situ cervicis uteri
Other
- Distant metastases verified by imaging or biopsy
- Pregnant or breastfeeding women
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Surgery, Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Unknown status |
| Department of Oncology, Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Unknown status |
| Department of Oncology, Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| Department of Surgery, Vejle Hospital Coordinator of this site? Confirm its status | Vejle | Denmark | Unknown status |
| Department of Oncology, Vejle Hospital Coordinator of this site? Confirm its status | Vejle | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.