Curative Chemoradiation of Low Rectal Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Curative Chemoradiation of Low Rectal Cancer. A Prospective Multicenter Observational Study

Conditions
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Rectal Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |