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Standard Dose Versus High Dose of Radiotherapy in Rectal Preservation With Chemo-radiotherapy in Rectal Cancer Patients
Sponsor: Vejle Hospital
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.
Official title: Randomized Trial of Standard Dose Versus High Dose of Radiotherapy in Rectal Preservation With Chemo-radiotherapy to Patients With Early Low and Mid Rectal Cancer: The Watchful Waiting 3 Trial (WW3)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
162
Start Date
2020-01-20
Completion Date
2033-12
Last Updated
2026-01-08
Healthy Volunteers
No
Conditions
Interventions
50.4 Gy to the tumor and elective volume
Standard radiotherapy
62 Gy to the clinical tumor volume and 50.4 Gy to the elective volume
Experimental radiotherapy
Capecitabine 825 mg/m2 twice daily on weekdays
Standard chemotherapy
Locations (5)
Aalborg University Hospital
Aalborg, Denmark
Copenhagen University Hospital, Righshospitalet and Bispebjerg Hospital
Copenhagen, Denmark
Zealand University Hospital, Næstved
Næstved, Denmark
Zealand University Hospital, Roskilde
Roskilde, Denmark
Department of Oncology, Vejle Hospital
Vejle, Denmark