Rectal Cancer
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Vejle Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with locoregional tumor control with chemoradiation alone two years after end of treatment | 2 years after end of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Cumulative incidence of local recurrence after surgery | Every two months the first year, every three months the second year, every six months the third year, and annually the fourth and fifth years |
| Rate of distant metastases | Every two months the first year, every three months the second year, every six months the third year, and annually the fourth and fifth years |
| Response and tumor control on MRI scans compared to clinical observations, including rectoscopic examination | 6 and potentially 12 weeks after end of treatment |
Countries
Denmark
Outcome results
None listed