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RECRUITING
NCT04095299
PHASE3

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

Sponsor: Vejle Hospital

View on ClinicalTrials.gov

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

Interventions

RADIATION

50.4 Gy to the tumor and elective volume

Standard radiotherapy

RADIATION

62 Gy to the clinical tumor volume and 50.4 Gy to the elective volume

Experimental radiotherapy

DRUG

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