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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Simultaneous integrated boost to the tumor and positive mesorectal lymph nodes
RadiationAddition of a simultaneous integrated boost (SIB) to the standard chemoradiotherapy (CRT) scheme of 2.0 Gy to the mesorectum. The radiotherapy scheme consists of 25 fractions, delivering 2.0 Gy per fraction to the mesorectum and 2.4 Gy per fraction to the tumor and positive mesorectal lymph nodes.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Simultaneous integrated boostExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Organ preservation
Organ preservation is considered unsuccessful if the rectum is surgically removed, a stoma is present, or a non-salvageable locoregional cancer recurrence is developed.
Time frame
During two-year follow-upSecondary outcomes
1
Rate of clinical complete response
Defined as the proportion of patients showing complete resolution of the tumor, assessed through endoscopy and MRI
Time frame
Assessed at the two response assessments (14-16 weeks and 26 weeks after the start of treatment)2
Rate of pathological complete response
Evaluated in patients undergoing surgical resection who did not achieve cCR. pCR is defined as the absence of any residual tumor in surgical specimens, assessed via histopathological examination.
Time frame
During two-year follow-up3
Local progression-free survival
Defined as the absence of tumor regrowth at or near the primary tumor site. Assessed through clinical evaluation and radiological imaging during the follow-up period.
Time frame
During two-year follow-up4
Distant progression-free survival
Defined as the absence of distant metastasis or death from any cause. Monitored with regular imaging and clinical evaluations during the follow-up period.
Time frame
During three-year follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Claudia Schuurhuizen
Lead sponsor
Erasmus Medical Center
Sponsor institution
Source ClinicalTrials.gov