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

Phase 3

• Conditions: Colorectal Cancer
• Interventions: Drug: systemic chemotherapy LV5FU2; Device: HAI-90Y radioembolization (SIR-spheres injection)

• Registration Number: NCT01895257
• Lead Sponsor: Universiteit Antwerpen

Brief 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)

Study Timeline

• Study First Submitted: 2013-06-06
• Study First Submitted QC: 2013-07-03
• Study First Posted: 2013-07-10
• Study Start: 2013-08
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-06
• Last Update Posted: 2017-07-07
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A: systemic chemotherapy LV5FU2 alone	systemic chemotherapy LV5FU2	Modified LV5FU2 as described in protocol (6.2.1) D1-2 +/- bevacizumab or cetuximab or panitumumab (according its previous use) every 2 weeks
B:SIR-spheres+systemic chemotherapy LV5FU2	HAI-90Y radioembolization (SIR-spheres injection)	ARM B: (Hepatic Arterial Infusion) HAI-90Y radioembolization (SIR-spheres injection) + modified LV5FU2 +/- bevacizumab or cetuximab or panitumumab according its previous use (refer to protocol).

Primary Outcome Measures

Name	Time	Method
Time to progression (TTP1 overall)	Up to 36 months	Time to first progression (TTP1 overall)

Secondary Outcome Measures

Name	Time	Method
Time to global progression (TTP1 + TTP2)	Up to 42 months	- Time to global progression (TTP1 + TTP2), Time to second progression (TTP2), TTP1 liver only
Quality of life	Up to 42 months	Using; * EORTC QLQ C30; * EQ-5D
Overall Survival (OS)	Up to 42 months
PFS	Up to 42 months	Progression free survival
R0 resection rate	Up to 42 months
Safety	Up to 42 months

Trial Locations

Locations (10)

CUB Hôpital Erasme; 🇧🇪 Brussels, Belgium

CHU de Liège; 🇧🇪 Liège, Belgium

University of Antwerp; 🇧🇪 Edegem, Antwerp, Belgium

ASZ Aalst; 🇧🇪 Aalst, Belgium

Institut Jules Bordet; 🇧🇪 Brussels, Belgium

University of St-Luc; 🇧🇪 Brussels, Belgium

Grand Hôpital de Charleroi; 🇧🇪 Charleroi, Belgium

ZOL Genk; 🇧🇪 Genk, Belgium

AZ St-Lucas Gent; 🇧🇪 Gent, Belgium

AZ Groeninge; 🇧🇪 Kortrijk, Belgium