Phase 3
N=209
FOLFOX6m Plus SIR-Spheres Microspheres vs FOLFOX6m Alone in Patients With Liver Mets From Primary Colorectal Cancer
Colorectal Cancer Metastatic
Bottom Line
View on ClinicalTrials.gov: NCT01721954 ↗Enrolled (actual)
209
Serious AEs
46.1%
Results posted
Oct 2019
Primary outcome: Primary: Overall Survival (OS) — 25.9; 25.0 months — p=0.43
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- FOLFOX6m (Drug); SIR-Spheres microspheres (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sirtex Medical
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
25.9; 25.0 | 0.43 |
| SECONDARY Progression-free Survival |
11.8; 11.2 | <0.05 sig |
Summary
This study is a randomized, multi-center study that will compare the efficacy and safety of selective internal radiation therapy (SIRT) using SIR-Spheres microspheres plus a standard chemotherapy regimen of FOLFOX6m versus FOLFOX6m alone as first-line therapy in patients with non-resectable liver metastases from primary colorectal carcinoma.
Treatment with the biologic agent bevacizumab, if part of the standard of care at participating institutions, is allowed within this study at the discretion of the Investigator.
Eligibility Criteria
Inclusion Criteria
- Age 18 years or older
- Willing and able to provide written informed consent
- Unequivocal and measurable CT evidence of liver metastases which are not treatable by surgical resection or local ablation
- Limited extra-hepatic metastases in the lung and/or lymph nodes are permitted (Lung: 5 lesions total, grade 2 (NCI-CTC)
- Dose-limiting toxicity associated with previous adjuvant 5-FU or oxaliplatin chemotherapy
- Prior non-adjuvant chemotherapy for any malignancy. Adjuvant chemotherapy for colorectal cancer is permitted provided that it was completed more than 6 months before entry into the study
- Pregnant or breast feeding
- Concurrent or prior history of cancer other than adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix
- Allergy to contrast media that would preclude angiography of the hepatic arteries
Data sourced from ClinicalTrials.gov (NCT01721954). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.