NL-OMON56792
Not yet recruiting
Phase 2
Single-arm, phase II trial of trifluridine/tipiracil (FTD-TPI), bevacizumab, and individualized radioembolization with 166Ho-microspheres in refractory metastatic colorectal cancer. - STARLIGHT
niversitair Medisch Centrum Utrecht0 sites40 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversitair Medisch Centrum Utrecht
- Enrollment
- 40
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Unresectable liver dominant mCRC
- •Prior therapy with fluoropyrimidine, oxaliplatin, and irinotecan for the
- •treatment of advanced colorectal cancer and had demonstrated progressive
- •disease or intolerance to their last regimen
- •Written informed consent
- •Age \>\=18 years
- •Estimated hepatic tumor replacement \>\= 10% and \<\= 50% of total liver volume
- •ECOG performance status 0\-1
- •Adequate organ function as measured by:
- •o WBC \>\= 3\.0 x 109/L, platelets \>\= 100 x 109/L, absolute neutrophil count \> 1\.5 x
Exclusion Criteria
- •Significant extrahepatic disease, defined as symptomatic extrahepatic
- •disease, greater than 10 pulmonary nodules (maximum diameter of each lung
- •metastasis \<20mm), and/or peritoneal carcinomatosis. (Definition of liver
- •dominant disease)(Fidelman et al., 2022\)
- •Eligible for local treatment of liver metastases (e.g. surgical resection,
- •Lung shunt \>20 Gy, as calculated using scout dose SPECT/CT
- •Absorbed tumor dose \<90 Gy when dosing at a maximum average absorbed normal
- •Other malignancy confounding prognosis
- •Receipt of chemotherapy within 28\*days prior to study treatment
- •Previous or current treatment with radioembolization
Outcomes
Primary Outcomes
Not specified
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