Standard Dose Versus High Dose of Radiotherapy in Rectal Preservation With Chemo-radiotherapy in Rectal Cancer Patients

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.

NCT Number	NCT04095299
Lead Sponsor	Vejle Hospital
Conditions	Cancer of Rectum
Enrollment	162 participants
Start Date	2020-01-20
Primary Completion	2026-12 (estimated)
Study Completion	2033-12 (estimated)
Updated on ClinicalTrials.gov	2026-01-08