At a glance
ClinicalIndex Comparison Record- ✓Histopathologically verified adenocarcinoma of the rectum
- ✓MDT conference finds patient a candidate for rectal resection
- ✓Clinical tumor category cT1-3
- ✓Maximal cross-sectional tumor size 4.5 cm or less on MRI
- ✕Previous surgical treatment of the present cancer including transanal excision
- ✕Other malignant disease within past five years except non-melanoma skin cancer and premalignant lesions
- ✕Distant metastases verified by imaging or biopsy (cM1)
- ✕Previous radiation treatment of the pelvis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating 50.4 Gy to the tumor and elective volume, 62 Gy to the clinical tumor volume and 50.4 Gy to the elective volume, and 1 other intervention for Cancer of Rectum. Currently recruiting, targeting 162 participants across 5 sites.
Detailed 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.
Study Details
Timeline
Interventions
Standard radiotherapy
Experimental radiotherapy
Standard chemotherapy