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
Parallel
50.4 Gy to the tumor and elective volume
RadiationStandard radiotherapy
62 Gy to the clinical tumor volume and 50.4 Gy to the elective volume
RadiationExperimental radiotherapy
Capecitabine 825 mg/m2 twice daily on weekdays
DrugStandard chemotherapy
Rectal preservation at two years
* Presence of a full-length rectum, i.e. no rectal resection. * Absence of rectal tumor, malignant lymph nodes or any other tumor deposit or recurrence within the pelvis based on clinical examination, CT and MR * No stoma because of side effects to treatment or rectal dysfunction
Rate of complete response within four months from start of radiotherapy
Locoregional recurrence (within the pelvis)
Relapse free survival
Overall survival
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