N/A
N=530
FOLFOX Plus SIR-SPHERES MICROSPHERES Versus FOLFOX Alone in Patients With Liver Mets From Primary Colorectal Cancer
Colorectal Cancer · Colorectal Carcinoma · Liver Metastases
Bottom Line
View on ClinicalTrials.gov: NCT00724503 ↗Enrolled (actual)
530
Serious AEs
47.7%
Results posted
Mar 2019
Primary outcome: Primary: Progression-Free Survival (PFS) at Any Site — 10.7; 10.2 Months — p=0.551
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SIR-Spheres yttrium-90 microspheres (Device); Systemic chemotherapy (FOLFOX) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sirtex Medical
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) at Any Site |
10.7; 10.2 | 0.551 |
| SECONDARY Percentage of Participants With Overall Response |
76.4; 68.1 | < 0.05 sig |
Summary
This study is a randomized multi-center trial that will assess the effect of adding Selective Internal Radiation Therapy (SIRT), using SIR-Spheres microspheres®, to a standard chemotherapy regimen of FOLFOX as first line therapy in patients with non-resectable liver metastases from primary colorectal adenocarcinoma.
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 treating Investigator.
Eligibility Criteria
Inclusion Criteria
- 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 1 (NCI-CTC).
- Dose limiting toxicity with previous adjuvant 5-FU or oxaliplatin chemotherapy.
- Prior non-adjuvant chemotherapy for any malignancy. Adjuvant chemotherapy for colorectal cancer is not an exclusion criteria provided that it was completed more than 6 months before entry into the study.
- Pregnant or breast-feeding.
- Other active malignancy.
Data sourced from ClinicalTrials.gov (NCT00724503). 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.