rectal cancer. rectal carcinoma
Conditions
Interventions
An irradiation boost of 15 Gy delivered to the gross tumor volume (GTV) in 5
fractions in addition to the standard chemoradiation treatment of 50 Gy.
Thereby increasing the total GTV dose to 65 Gy.
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Participant in the PLCRC project (METC 12-510). * Informed consent obtained for being offered experimental interventions within the PLCRC project. * Informed consent obtained for questionnaires on patient reported outcomes within the PLCRC project. * WHO: 0-2. * T3+ (circumferential resection margin (CRM) positive) T4N0-1 or N2 M0-1 (if resectable liver and/or lung metastases). * Referred for chemoradiation. * No contra-indication for MRI. * Tumor distance from ano-rectal transition *10cm.
Exclusion criteria
Exclusion criteria: * T3 (limited volume / CRM negative). * Inflammatory bowel disease. * Prior pelvic radiotherapy. * At least one contra-indication for capecitabine administration (based on DPD-deficiency, blood count, liver malfunction, renal failure (Creatinine clearance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is complete response either defined as pathological complete response (pCR) in patients who undergo surgery, assessed by standardized pathologic examination of the surgical specimen, or 2-years local recurrence-free survival (LFRS) after chemoradiation in patients who opted for a wait and see approach. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are treatment acute, perioperative and late toxicity, tumor response assessed with MRI, patient-reported quality of life and workability, local recurrence and (disease-specific) survival. | — |
Countries
Netherlands
Outcome results
None listed