drugset / Trial / NCT04095299

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

NCT04095299 ↗

Phase 3 Recruiting 162 enrolled Vejle Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2020-01-20
Primary completion
2026-12
Completion
2033-12

Drugs

EvaluationDrugModalityDoseRoute
Background Capecitabine Small molecule 825 mg/m2 —

Indications