Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
NCT ID:
NCT05375708
Eligibility Criteria:
Inclusion Criteria:
* Registered in the prospective Dutch colorectal cancer cohort (PLCRC)
* Intention at start of palliative systemic therapy to receive six maximum tolerated dose (MTD) cycles of CAPOX-B or eight MTD cycles of FOLFOX-B or FOLFOXIRI-B.
* Ten or less metastases as determined by the university medical center Utrecht (UMCU) central review
* Stable disease or partial response after initial chemotherapy according to RECIST 1.1 criteria.
* Expected adequacy of follow-up
* World Health organization (WHO) performance status 0-1
* Life expectancy \>12 weeks
* Adequate organ functions at start of initial therapy, as determined by normal bone marrow function (Hb≥6.0 mmol/L, absolute neutrophil count ≥1.5 x 10\^9/L, platelets ≥100 x 10\^9/L), renal function (serum creatinine ≤ 1.5x upper limit of normal (ULN) and creatinine clearance, Cockcroft formula, ≥30 ml/min) and liver function (serum bilirubin ≤ 2 x ULN, serum transaminases ≤ 3 x ULN without presence of liver metastases or ≤ 5x ULN with presence of liver metastases)
* Written informed consent (SIRIUS)
Exclusion Criteria:
* Less than three cycles of CAPOX-B or four cycles of FOLFOX-B or FOLFOXIRI-B (dose reductions allowed).
* More than six cycles of CAPOX-B or eight cycles of FOLFOX-B of FOLFOXIRI-B.
* 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.
* Not amenable for radiotherapy (e.g. peritonitis carcinomatosa)
* Previous systemic treatment for metastatic disease; prior adjuvant treatment for stage II/III colorectal cancer when given \>6 months before the start of initial systemic treatment is allowed.
* Serious comorbidity or any other condition preventing the safe administration of treatment (including both systemic treatment and radiation)
* Pregnant or lactating women
* Other malignancy interfering with prognosis
* Any concomitant experimental treatment.
* Contra-indication MR-LINAC (pacemaker or implantable cardioverter-defibrillator)
* Microsatellite instability or deficient mismatch repair tumor
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05375708
Study Brief:
Protocol Section:
NCT05375708