Higher Radiation Dose to the Tumor May Help Avoid Surgery in Rectal Cancer Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClaudia Schuurhuizen
About this trial
The goal of this prospective study is to evaluate if a higher radiation dose to the tumor can increase the organ preservation rate in non-locally advanced rectal cancer.
Eligibility criteria
Qualifiers
Age ≥18 years
Eastern cooperative oncology group (ECOG) performance status ≤2
Histologically confirmed rectal adenocarcinoma
Non-locally advanced rectal cancer, defined as (magnetic resonance imaging (MRI)-based) T1-3, N0/N1 (≤3 positive mesorectal lymph nodes), MX/M0
Disqualifiers
Previous radiotherapy in the pelvic area
Other malignancies, except for adequately treated basal cell carcinoma (BCC), at time of inclusion or within 3 years prior to inclusion
Contra-indications for (chemo)radiotherapy or surgery
Presence of lateral lymph nodes, cN2 status, extramural vascular invasion (EMVI) or mesorectal fascia involvement as seen on MRI
Trial design
Treatments tested in this trial
- Simultaneous integrated boost to the tumor and positive mesorectal lymph nodes
Treatment groups
25 Participants
are divided into 1 treatment groupLocations
1Erasmus MC3015 GD, RotterdamSouth Holland, Netherlands
Sponsors and collaborators
Claudia Schuurhuizen
Lead sponsor
Erasmus Medical Center
Sponsor institution
Source ClinicalTrials.gov