Actively Recruiting
Standard Dose Versus High Dose of Radiotherapy in Rectal Preservation With Chemo-radiotherapy in Rectal Cancer Patients
Led by Vejle Hospital · Updated on 2026-01-08
162
Participants Needed
5
Research Sites
723 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Standard Dose Versus High Dose of Radiotherapy in Rectal Preservation With Chemo-radiotherapy in Rectal Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathologically verified adenocarcinoma of the rectum
- Patient considered a candidate for rectal resection by multidisciplinary team
- Clinical tumor category cT1-3
- MRI showing tumor size up to 4.5 cm in cross-section
- Tumor located at or below the peritoneal reflection on MRI
- Performance status 0 to 2
- Age 18 years or older
- Eligible for radiotherapy and capecitabine treatment
- Adequate bone marrow, liver, and kidney function
- Fertile women must have a negative pregnancy test and use secure contraception during and for 3 months after treatment
- Provided written and oral informed consent
You will not qualify if you...
- Previous surgery for current rectal cancer, including transanal excision
- Other malignant disease within past 5 years except non-melanoma skin cancer or premalignant lesions
- Presence of distant metastases (cM1) confirmed by imaging or biopsy
- Previous radiation treatment to the pelvis
- Pregnant or breastfeeding women
- Existing colostomy or ileostomy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Aalborg University Hospital
Aalborg, Denmark
Actively Recruiting
2
Copenhagen University Hospital, Righshospitalet and Bispebjerg Hospital
Copenhagen, Denmark
Actively Recruiting
3
Zealand University Hospital, Næstved
Næstved, Denmark
Actively Recruiting
4
Zealand University Hospital, Roskilde
Roskilde, Denmark
Actively Recruiting
5
Department of Oncology, Vejle Hospital
Vejle, Denmark
Actively Recruiting
Research Team
L
Lars H Jensen, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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