Actively Recruiting
REctal Organ Preservation With a BOost Approach Using CBCT-based Online Adaptive radioTherapy
Led by Claudia Schuurhuizen ยท Updated on 2026-06-01
25
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether a higher radiation dose to the tumor can increase the rate of preserving the rectum in patients with non-locally advanced rectal cancer. This prospective study focuses on patients who want to avoid surgery and aims to improve quality of life by reducing long-term side effects. The trial explores a new radiation approach using cone-beam computed tomography (CBCT) for more accessible and adaptive treatment compared to MRI-guided methods. The study involves adding a simultaneous integrated boost (SIB) to the standard chemoradiotherapy regimen. Patients receive 25 radiation sessions where the mesorectum gets 2.0 Gy per fraction and the tumor plus affected lymph nodes receive 2.4 Gy per fraction. This single-arm trial includes 25 patients and uses CBCT imaging daily to guide treatment and monitor tumor and organ movement. Participants will have five MRI scans during treatment weeks, complete questionnaires at five time points, and provide blood samples to assess treatment effects and safety. Researchers will track organ preservation rates over two years, clinical and pathological responses, survival outcomes, bowel function, quality of life, and any treatment-related toxicities. The total follow-up lasts up to three years for some outcomes, with regular assessments to understand the effectiveness and impact of this adapted radiation therapy.
CONDITIONS
Brief Title
Higher Radiation Dose to the Tumor May Help Avoid Surgery in Rectal Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 2 or less
- Histologically confirmed rectal adenocarcinoma
- Non-locally advanced rectal cancer defined as MRI-based T1-3, N0/N1 (up to 3 positive mesorectal lymph nodes), MX/M0
- Suitable for curative treatment aiming for organ preservation
- Case discussed in multidisciplinary tumor board
- Provided written informed consent
You will not qualify if you...
- Previous radiotherapy in the pelvic area
- Other cancers except adequately treated basal cell carcinoma within 3 years prior
- Contraindications for chemoradiotherapy or surgery
- Presence of lateral lymph nodes, cN2 status, extramural vascular invasion, or mesorectal fascia involvement on MRI
- Mucinous type tumor on MRI
- Prior local excision of the primary tumor
- Dihydropyrimidine dehydrogenase (DPD) deficiency
- Unable to understand study requirements or provide informed consent as determined by physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 weeks
Participants receive a combined chemoradiotherapy with a simultaneous integrated boost to the tumor and positive mesorectal lymph nodes over 5 weeks.
Daily visits for radiation treatment and weekly MRI scans during treatment
Duration - Up to 2 years
Participants are monitored for organ preservation, treatment response, toxicities, bowel function, quality of life, and survival outcomes for up to two years after treatment.
Multiple visits including response assessments at 14-16 weeks and 26 weeks, and questionnaires at baseline, 3, 6, 12, and 24 months
Trial Site Locations
Total: 1 location
1
Erasmus MC
Rotterdam, South Holland, Netherlands, 3015 GD
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here