Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-26 @ 6:36 AM
Study NCT ID:
NCT01895257
Status:
UNKNOWN
Last Update Posted:
2017-07-07
First Post:
2013-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing HAI-90Y (SIR-spheres)+Chemotx LV5FU2 Versus Chemotx LV5FU2 Alone to Treat Colorectal Cancer
Sponsor:
Universiteit Antwerpen
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2017-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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)
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2012-000508-14 | EUDRACT_NUMBER | None | View |