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Radiosensitization of AVASTIN® (Bevacizumab) With Stereotactic Body Radiotherapy for Colorectal Liver Metastasis

NCT01569984 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2016-10-13

No results posted yet for this study

Summary

This is a single-centre, single-arm open-label proof-of-concept study to analyze the imaging (DCE-CT,CEUS and Quantitative US) effects of neoadjuvant bevacizumab and SBRT on colorectal metastases to the liver. Patients will receive 2 doses of bevacizumab 5mg/kg IV prior to SBRT. The second dose of bevacizumab will be given 2 weeks after the first dose of bevacizumab and within 48 hours of starting the first dose of SBRT. The SBRT prescription dose will be up to 60 Gy in 6 fractions, delivered on alternating weekdays for 2 weeks. Total SBRT dose will be determined by size of target lesion, liver sparing and organs-at-risk dose constraints. DCE-CT, CEUS and Quantitative US will be performed within 7 days prior to the first dose of bevacizumab, after the second dose of bevacizumab and within 7 days of completing SBRT.

Conditions

  • Colorectal Cancer.

Interventions

RADIATION

Stereotactic body radiotherapy

Avastin 7.5 mg/kg IV x 2 doses 14 days apart

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Dr. Yoo-Joung Ko

    lead OTHER

Principal Investigators

  • Yoo-Joung Ko, MD · Sunnybrook Health Sciences Centre

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • Canada

Study Locations

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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 NCT01569984 on ClinicalTrials.gov