Bowel cancer colon cancer rectum cancer
Conditions
Interventions
SBRT on all metastatic sites followed by maintenance treatment.
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Histological proof of colorectal carcinoma (CRC) - Colorectal metastatic disease - Ten or less metastases as determined by the UCMU central review - Stable disease or partial response after induction chemotherapy according to RECIST 1.1 criteria - Written informed consent For all in- and exclusion criteria we want to refer to chapter 4 of the protocol.
Exclusion criteria
Exclusion criteria: - Possible treatment with curative intent according to local tumor board - Substantial overlap with a previously treated radiation volume. Previous radiotherapy is allowed as long as the composite plan meets dose constraints herein. - Contra-indication MR-LINAC (pacemaker or implantable cardioverter-defibrillator) For all in- and exclusion criteria we want to refer to chapter 4 of the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lead-in: Feasibility, based on technical feasibility, logistical feasibility and patient acceptance (details are provided in the protocol) Phase II: Progression free survival. Defined as the time from randomization until progression of disease or death, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Lead-in: Secondary outcome: Grade II adverse events of specific interest and grade III/IV adverse events. Phase II: Overall survival, objective response rate of SBRT, time to disease related treatment failure, health related quality of life, depth of response, pattern of recurrence, treatment success rate, grade II adverse events of specific interest and grade III/IV adverse events of SBRT and fatigue measurements by MFI-20. | — |
Countries
Netherlands
Outcome results
None listed