Overview

This trial is active, not recruiting.

Conditions colorectal cancer, colorectal carcinoma, liver metastases
Treatments systemic chemotherapy (folfox), sir-spheres yttrium-90 microspheres
Sponsor Sirtex Medical
Start date August 2006
End date September 2014
Trial size 518 participants
Trial identifier NCT00724503, STX0206

Summary

This study is a randomized multi-center trial that will assess the effect of adding 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5- Fluorouracil (FOLFOX)
systemic chemotherapy (folfox) FOLFOX6m
Oxaliplatin 85 mg/m2, IV infusion, q two weeks Leucovorin 200 mg/m2, IV infusion, q two weeks 5-Fluorouracil 400 mg/m2, IV bolus, q two weeks 5-Fluorouracil 2.4 g/m2, IV infusion, q two weeks
(Active Comparator)
A single injection of SIR-Spheres microspheres into the liver plus systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)
sir-spheres yttrium-90 microspheres SIRT
SIR-Spheres microspheres implanted once on the 3rd or 4th day of the first week of the first chemotherapy cycle
systemic chemotherapy (folfox) FOLFOX6m
Oxaliplatin 60 mg/m2,IV infusion, q two weeks for first 3 cycles Oxaliplatin 85 mg/m2, IV infusion, q two weeks from cycle 4 onwards Leucovorin 200 mg/m2, IV infusion, q two weeks 5-Fluorouracil 400 mg/m2, IV bolus, q two weeks 5-Fluorouracil 2.4 g/m2, IV infusion, q two weeks

Primary Outcomes

Measure
progression free survival
time frame: from randomisation until progressive disease is confirmed or upon patient death if disease progression has not been evident at that time

Eligibility Criteria

Male or female participants at least 18 years old.

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, < 1 cm, or 1 single lesion of up to 1.7 cm; Lymph nodules in one single anatomic area (pelvis, abdomen or chest): any number, < 2 cm). - Suitable for either treatment regimen. - Prior chemotherapy for metastatic colorectal cancer is not allowed. - WHO performance status 0-1. - Adequate hematological, renal and hepatic function. - Age 18 years or older. - Willing and able to provide written informed consent. - Life expectancy of at least 3 months without any active treatment. Exclusion Criteria - Evidence of ascites, cirrhosis, portal hypertension, main portal or venous tumor involvement or thrombosis as determined by clinical or radiologic assessment. - Previous radiotherapy delivered to the upper abdomen. - Non-malignant disease that would render the patient unsuitable for treatment according to the protocol. - Peripheral neuropathy > 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.

Additional Information

Official title Randomised Comparative Study Of Folfox6m Plus Sir-Spheres® Microspheres Versus Folfox6m Alone As First Line Treatment In Patients With Nonresectable Liver Metastases From Primary Colorectal Carcinoma
Principal investigator Peter Gibbs, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Sirtex Medical.