NCT04095299RecruitingPhase 3
Standard Dose Versus High Dose of Radiotherapy in Rectal Preservation With Chemo-radiotherapy in Rectal Cancer Patients
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)
Source: ClinicalTrials.gov · Last updated 8 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 162 (estimated)
- First submitted
- 17 Sept 2019
- Start date
- 20 Jan 2020
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Vejle Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT04095299
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 162
- From 20 Jan 2020 to the primary completion date, 31 Dec 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous surgical treatment of the present cancer, including transanal excision of tumor
- Previous radiation treatment of the pelvis
Other illness
- Other malignant disease within the past five years except non-melanoma skin cancer and premalignant lesions such as carcinoma in situ
Other
- Distant metastases verified by imaging or biopsy, i.e. cM1
- Pregnant or breastfeeding women.
- Existing colostomy or ileostomy
Who the study is looking for
- Histopathologically verified adenocarcinoma of the rectum
- MDT conference finds patient a candidate for rectal resection
- Clinical tumor category cT1-3
- MRI findings
- Maximal cross-sectional size of 4.5 cm (axial plane relative to the rectum)
- Lowest edge of tumor located at or below the peritoneal reflection on MRI
- Performance status 0-2
- Age ≥ 18 years
- Eligible for radiotherapy and capecitabine according to investigator, including
- Adequate function of bone marrow (neutrophils ≥ 1.5 x 10\^9/l and thrombocytes ≥ 100 x 10\^9/l)
- Adequate function of liver (ALAT \< 2.5 x upper limit of normal, bilirubin \< 2.5 x upper limit of normal)
- Adequate kidney function (Serum creatinine \< 1.5 x upper limit of normal or measured GFR \> 30 ml/min)
- Fertile women must present a negative pregnancy test and use secure contraceptives during and three months after treatment
- Written and orally informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Recruiting |
| Copenhagen University Hospital, Righshospitalet and Bispebjerg Hospital Coordinator of this site? Confirm its status | Copenhagen | Denmark | Recruiting |
| Zealand University Hospital, Næstved Coordinator of this site? Confirm its status | Næstved | Denmark | Recruiting |
| Zealand University Hospital, Roskilde Coordinator of this site? Confirm its status | Roskilde | Denmark | Recruiting |
| Department of Oncology, Vejle Hospital Coordinator of this site? Confirm its status | Vejle | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.