NCT01895257

Comparing HAI-90Y (SIR-spheres)+Chemotx LV5FU2 Versus Chemotx LV5FU2 Alone to Treat Colorectal Cancer

A Randomised Phase III Trial Comparing Hepatic Arterial Injection of Yttrium-90 Resin Microspheres (SIR-spheres) Plus Systemic Maintenance Therapy Versus Systemic Maintenance Therapy Alone for Patients With Unresectable Liver Metastases From Colorectal Cancer Which Are Controlled After Induction Systemic Therapy

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 162 (estimated)
• Sponsor: Universiteit Antwerpen · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The investigators propose to conduct a randomised phase III trial evaluating a maintenance strategy comparing hepatic arterial injection of Yttrium-90 resin microspheres plus continuing simplified chemotherapy with/without targeted therapy versus continuing simplified chemotherapy with/without targeted therapy alone for patient with dominant or exclusive and unresectable liver mCRC controlled after 3-6 months of chemotherapy induction.

Detailed description

The aim of the study is to investigate whether an intensified maintenance treatment of SIRT + simplified maintenance chemotherapy has a benefit in terms of time to progression (TTP) compared to simplified chemotherapy maintenance alone, in patients with stable disease after 3-6 months induction therapy. We would like to demonstrate the feasibility and safety of this approach and to investigate if this strategy has the potential to increase the outcome of the patient. Primary end-point: \- Time to first progression (TTP1 overall) Secondary end-points: * Time to global progression (TTP1 + TTP2), Time to second progression (TTP2), TTP1 liver only * Progression Free Survival (PFS) * Overall Survival (OS) * Safety * Ro resection rate * Quality of Life Exploratory analysis: \- Prediction and evaluation of SIR-spheres treatment response (only for Belgian centres)

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DEVICE	HAI-90Y radioembolization (SIR-spheres injection)	Patients randomised to receive the combination of SIR-Spheres microspheres plus systemic chemotherapy LV5FU2 need to be assessed in order to determine their suitability for SIRT. 1. Hepatic Angiogram 2. Liver-Lung Break-Through Nuclear Scan
DRUG	systemic chemotherapy LV5FU2	Systemic chemotherapy with modified LV5FU2 will be administered according to the following regimen. Cycle 1 onwards: Day 1 Hour 0: Leucovorin L (levoleucovorin) 200 mg/m2 (or folinic acid 400 mg/m²) in 250 ml glucose 5%, 2-hour IV infusion Hour + 2: 5-FU bolus 400 mg/m2, IV bolus Hour + 2: 5-FU continuous infusion 2400 mg/m2, 46-hour cont. IV infusion Day 14 End of cycle. To be repeated every 14 days until evidence of treatment failure.

Timeline

• Start date: 2013-08-01
• Primary completion: 2017-12-01
• Completion: 2018-12-01
• First posted: 2013-07-10
• Last updated: 2017-07-07

Locations

10 sites across 1 country: Belgium