In recent years, an increasing number of retrospective and prospective observational studies have indicated that a subset of rectal cancer patients may avoid surgery if they can achieve a complete response to chemoradiotherapy. Prospective trials, including the previous Danish Watchful Waiting trials (NCT00952926, NCT02438839) in early rectal cancer have demonstrated high levels of organ preservation with dose-escalation, but it is unclear whether this was primarily due to tumor stage or dose level.
The aim of the present study is to investigate if a higher dose of radiotherapy is superior compared to a standard dose in patients with early rectal cancer undergoing chemoradiotherapy with curative intent.
Histopathologically verified adenocarcinoma of the rectum
MDT conference finds patient a candidate for rectal resection
Clinical tumor category cT1-3
MRI findings
Previous surgical treatment of the present cancer, including transanal excision of tumor
Other malignant disease within the past five years except non-melanoma skin cancer and premalignant lesions such as carcinoma in situ
Distant metastases verified by imaging or biopsy, i.e. cM1
Previous radiation treatment of the pelvis