Rectal carcinoma Rectal cancer
Conditions
Interventions
Addition of a simultaneous integrated boost (SIB) to standard chemoradiotherapy (CRT), 
delivering 2.4 Gy to the tumor and positive mesorectal lymph nodes instead of the standard 2.0 Gy using CBCT-guided online adaptive radiotherapy.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age =18 years Eastern cooperative oncology group (ECOG) performance status =2Histologically confirmed rectal adenocarcinomaNon-locally advanced rectal cancer, defined as (magnetic resonance imaging (MRI)-based) T1-3, N0/N1 (=3 positive mesorectal lymph nodes), MX/M0 Indication for curative treatment with organ preservationDiscussed in the multidisciplinary tumor board (MTB) Written informed consent
Exclusion criteria
Exclusion criteria: Previous radiotherapy in the pelvic areaOther malignancies, except for adequately treated basal cell carcinoma (BCC), at time of inclusion or within 3 years prior to inclusionContra-indications for (chemo)radiotherapy or surgeryPresence of lateral lymph nodes, cN2 status, extramural vascular invasion (EMVI) or mesorectal fascia involvement as seen on MRI Mucinous defined tumor on MRI Prior local excision of the primary tumor DPD (dihydropyrimidine dehydrogenase) deficiency Unable to understand the requirements of the study and to give written informed consent, as determined by the treating physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study aims to demonstrate that, in patients with non-locally advanced rectal cancer, the investigated treatment approach results in an increased organ preservation rate of 70% at two-year follow-up compared to historical data. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are to assess additional clinical, biological, functional, technical, and workflow outcomes:Clinical and pathological complete response rates (cCR and pCR). Local and distant progression-free survival, and overall survival.Biological effect of the treatment, assessed through blood analysis.Toxicity, evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.Bowel function and quality of life, assessed using the Low Anterior Resection Syndrome (LARS) score and the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-CR29 questionnaires.Tumor regression during treatment, monitored through weekly MRI scans.Target and organ intra- and interfraction motion to assess the potential for margin reduction in online adaptive radiotherapy.Evaluate the SIB online adaptive workflow.Surgical complications, if applicable, classified using the Clavien-Dindo system. | — |
Countries
Netherlands
Contacts
Public ContactJ.H. Sluijter
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed