Short summary

Danish and foreign single center studies have shown very promising results with a high success rate of curative chemoradiation of low rectal cancer. It may be argued, however, that these favorable results have only been obtained in specialized centers and expert hands. Thus, the time has come to investigate whether the results can be reproduced in the daily clinical setting. 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.

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Rationale

Low rectal cancer, defined as tumors located less than 6 cm from the anal verge, constitutes a therapeutic problem. The smallest tumors can often be resected, but larger tumors are mainly treated with abdominoperineal resection (APR) and a permanent stoma or ultra-low anastomosis, which are mutilating procedures with serious consequences. Since the surgical treatment of these tumors involves a high rate of short and long-term complications, there is a need for alternative treatment options.

Preoperative radiotherapy reduces the risk of local recurrence by approximately 50% and adding concomitant chemotherapy will improve the effect. Standard chemoradiation causes tumor shrinkage in approximately 80% of the patients and in a fraction of these (15-25%) the tumor will have disappeared completely at surgery.

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.

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Description of the cohort

Patients with low T1-3 rectal cancer where the local tumor board recommends protocol participation are evaluated for protocol inclusion according to eligibility criteria.

Data and biological material

Patient demographics.

Results of diagnostic procedures.

Radiologic evaluations before, during and after therapy.

Clinical follow-up.

Side effects, QoL, symptom scores.

A biobank will be established at Vejle Hospital for translational research. Blood samples (39 ml) will be drawn before start of treatment, in week 3 of the treatment course, and at the end of treatment. The same amount of blood will be drawn at each follow-up visit.

Collaborating researchers and departments

Institutions willing to comply with the protocol are welcomed to participate.

Departments will be added here after inclusion of their first patient.