Locally recurrent rectal cancer Recurrent rectal cancer
Conditions
Interventions
All cases are reviewed in a multidisciplinary tumour board before enrolment. Interventions are defined as follows: 
(Chemo-)reirradiation: 
 
SBRT (daily adaptive MR or CBCT-guided) will be delivered when feasible, depending on tumour characteristics (i.e., <
6 cm in tumour diameter, and tumour not infiltrating the lumen of the bowel- or bladder wall, as in accordance with the UK SBRT consortium guidance). The SBRT regimen consists of 5 fractions of 9 Gy.
concurrent capecitabine 825mg/m2 BD. 
Full-course chemoradiotherapy: 
delivered with a simultaneous integrated boost (SIB) technique (25x2.6 Gy), corresponding to an EQD2Gy (a/ß = 5 Gy, rectum) of 71 Gy, 
with concurrent capecitabine 825mg/m2 BD. 
Sponsors
Catharina Ziekenhuis
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Age = 18 years old. Diagnosis of locally recurrent rectal cancer, defined as: Recurrent disease within the pelvis after surgical excision for primary rectal or distal sigmoidal cancer, diagnosed either by histopathology or clinically proven (evidence on imaging in combination with clinical findings, with consensus in MDT). A second recurrence is eligible if (chemo-)reirradiation is considered feasible, with consensus in MDT. Recurrent disease is determined as unresectable where surgery has been ruled out by clinicians (or refused by patient), with consensus in MDT. Unresectable is defined as: expected gross incomplete resection with overt tumour remaining in the patient after resection, encasement of the ischiadic nerve and invasion of the cortex and/or neuroforamina from S2 and upwards. Either radiological absence of distant metastatic disease (M0), or, with (oligo)metastatic disease that does not require imminent start of systematic therapy at time of inclusion. WHO/ECOG performance score 0-2.MR pelvis and thoracoabdominal CT with interpretation no longer than 6 weeks prior to inclusion.Written informed consent according to the ICH-GCP and national/local regulations.
Exclusion criteria
Exclusion criteria: Radiological evidence of extensive metastatic disease (e.g., extensive liver or lung metastases) at time of inclusion, that requires imminent start of systemic therapy, with consensus in MDT. Radiotherapy in the past 6 months. Any contraindication for planned radiotherapy dose escalation, as determined by the radiation oncologist (e.g., residual grade 3 toxicity from previous radiotherapy). Administration of bevacizumab/panitumumab/cetuximab <6 weeks prior to start radiotherapy dose escalation.Severe active morbidity, concomitant disease or active infections. dMMR/MSI status
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to evaluate the feasibility of radiotherapy dose escalation, as defined by the incidence of acute (3 months) grade 3-5 radiation-induced toxicities =7 participants (CTCAE version 5.0). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives include late radiation-induced toxicity, quality of life and symptomatic control (using validated patient-reported outcome questionnaires), and 1- and 3- year (infield and outfield) progression-free survival (PFS), disease-free survival (DFS) and overall survival (OS). | — |
Countries
Netherlands
Contacts
Public ContactH.M.U. Peulen
Catharina Ziekenhuis
Outcome results
None listed