Organ Preservation in Rectal Cancer by Dose Escalated MR Guided Adaptive Radiotherapy
ConditionRectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Tuebingen
About this trial
This study is testing whether radiation delivered with MRI guidance using a so-called MR-linac in distal rectal cancer can result in a high rate of organ preservation. Patients will receive radiotherapy together with standard chemotherapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with histologically confirmed diagnosis of rectal cancer localized between dentate line and 12 cm from the anocutaneous line
Any MRI staged rectal cancer meeting the following criteria
cT1-cT3 and
cN0 -cN1 and
Disqualifiers
Lower border of the tumor localised more than 12 cm from the anocutaneous line as measured by rigid rectoscopy
Distant metastases
Preexisting fecal incontinence for solid stool
Prior antineoplastic therapy for rectal cancer
Trial design
Design model
Single group
Treatments tested in this trial
Dose escalated radiotherapy using a 1.5 T MR-Linac
RadiationDose escalated radiotherapy using a 1.5 T MR-Linac is given to the primary tumor and affected lymph nodes in an online adaptive manner
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: MR guided dose escalated radiotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Two year TME-free survival
Patients alive and without TME-surgery
Time frame
Two years from the start of radiotherapySecondary outcomes
1
Clincal complete response rate
Patients who have no evidence of residual tumor on MRI and rectoscopy
Time frame
three months after the end of radiotherapySponsors and contacts
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Source ClinicalTrials.gov