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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Proportion of patients with locoregional tumor control with chemoradiation alone two years after end of treatment — 2 years after end of treatment
Trial sites (5)
Facility
City
Region
Status
Department of Oncology, Aalborg University Hospital
Aalborg
Denmark
Department of Surgery, Aalborg University Hospital
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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