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

NCT01895257 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2017-07-07

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Universiteit Antwerpen

    lead OTHER

Principal Investigators

  • Marc Peeters · Universiteit Antwerpen

  • Marc Van den Eynde · University of St-Luc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2017-12-31
Completion
2018-12-31

Countries

  • Belgium

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01895257 on ClinicalTrials.gov