- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01569984
Radiosensitization of AVASTIN® (Bevacizumab) With Stereotactic Body Radiotherapy for Colorectal Liver Metastasis (SBRT-Avastin)
October 12, 2016 updated by: Dr. Yoo-Joung Ko
An Open Label, Single-Centre, Phase II Study for Radiosensitization of AVASTIN® (Bevacizumab) With Stereotactic Body Radiotherapy (SBRT) for Colorectal Liver Metastasis (SBRT Avastin)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histological and/or cytological diagnosis of colorectal cancer with liver metastases confirmed on imaging scans
- 1-3 liver metastatic lesions confirmed on imaging scans
- Maximum size of target metastatic lesion is 6 cm or less
- At least 700 cc of liver uninvolved by tumour
- Previous liver resection, systemic therapy or local ablation therapy is allowed. Extrahepatic disease is allowed if maximum involved organs (including the liver) is 3 or less (i.e. oligometastases).
- Child-Pugh's A liver function
- Male or female: Age ≥ 18 years
- Life expectancy > 3 months
- ECOG PS < 2
- Prior bevacizumab is permitted as long as last dose >28 days from registration
Laboratory Requirements - within 7 days prior to registration: Hematology
- neutrophils ≥ 1.5 x 109/L
- platelets ≥ 100 x 109/L
- hemoglobin ≥ 90 g/L Biochemistry
- bilirubin ≤ 1.5 x upper limit of normal
- serum creatinine ≤ 1.5 x upper limit of normal
- AST ≤ 3 x upper limit of normal (≤ 5 x if liver metastases present)
- ALT ≤ 3 x upper limit of normal (≤ 5 x if liver metastases present)
- INR ≤ 1.3 Urinalysis
- Proteinuria ≤ grade 1 (by dipstick)
- Patients are willing to provide informed consent.
- Patients must be accessible for treatment and follow up. Patients registered on this trial must be treated and followed at the participating centre
Exclusion Criteria:
- Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to registration (i.e. patients must have recovered to less than or equal to grade 1 from any major surgery), or anticipation of need for major surgical procedure during or within 7 weeks after chemo-radiotherapy.
- Known to have clinical or radiological evidence of CNS metastases.
- Patients with a past or current history (within last 2 years) of other malignancies, except for the indication under this study and curatively treated basal and squamous skin cancer or in-situ cancer of the cervix. Prior treatment of localized prostate cancer is permitted if treatment was greater than 5 years ago and the patient currently has no biochemical evidence of recurrence.
- Active hepatitis (infectious or non-infectious)
- Patients with known history or present encephalopathy
- Gross clinically detectable ascites
- Women of childbearing potential with a positive pregnancy test at baseline or lactating. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non childbearing potential. Females patients must not be pregnant or become pregnant during this study and for 6 months after the last dose of bevacizumab.
- Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study. Patients of childbearing potential must be willing to use a reliable method of birth control. i.e.:double barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device or tubal ligation during the study.
- Prior radiotherapy to the right upper quadrant of the liver
- Known hypersensitivity reaction to bevacizumab
- Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanised antibodies
- Uncontrolled hypertension, defined as SBP > 150/100 on more than one occasion that does not respond to therapy with antihypertensive agents or being treated with more than 2 anti-hypertensive medications.
- Any other serious intercurrent illness such as cardiovascular disease, HIV or any neurological disease.
- Patients taking other approved or investigational drug/anticancer treatment (other than ongoing androgen ablation and oral prednisone which are permitted) during the study period, including chemotherapy, biological response modifiers, immunotherapy, surgery or radiotherapy.
- Patients concurrently participating in another clinical trial
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Avastin, SBRT
2 treatments of avastin followed by 6 treatments of SBRT every other day.
|
Avastin 7.5 mg/kg IV x 2 doses 14 days apart
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor perfusion
Time Frame: day 24
|
Tumor perfusion as measured by DCE-CT
|
day 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood flow
Time Frame: Day 24
|
Contrast Enhanced Ultrasound
|
Day 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Yoo-Joung Ko, MD, Sunnybrook Health Sciences Centre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
March 30, 2012
First Submitted That Met QC Criteria
March 30, 2012
First Posted (Estimate)
April 3, 2012
Study Record Updates
Last Update Posted (Estimate)
October 13, 2016
Last Update Submitted That Met QC Criteria
October 12, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Bevacizumab
Other Study ID Numbers
- OZM-032
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Colorectal Cancer.
-
University of California, San FranciscoCompletedStage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditionsUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)TerminatedRectal Cancer | Colon Cancer | Cancer Survivor | Colorectal Adenocarcinoma | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage... and other conditionsUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedStage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditionsUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedCancer Survivor | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage IIA Colorectal Cancer AJCC v8 | Stage IIB Colorectal... and other conditionsUnited States
-
M.D. Anderson Cancer CenterRecruitingColorectal Adenocarcinoma | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage... and other conditionsUnited States
-
City of Hope Medical CenterRecruitingColorectal Neoplasms | Colorectal Cancer | Colorectal Adenocarcinoma | Colorectal Cancer Stage II | Colorectal Cancer Stage III | Colorectal Cancer Stage IV | Colorectal Neoplasms Malignant | Colorectal Cancer Stage IUnited States, Japan, Italy, Spain
-
Sidney Kimmel Cancer Center at Thomas Jefferson...United States Department of DefenseActive, not recruitingColorectal Adenoma | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage 0 Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage IIA Colorectal... and other conditionsUnited States
-
University of Roma La SapienzaCompletedColorectal Cancer Stage II | Colorectal Cancer Stage III | Colorectal Cancer Stage IV | Colorectal Cancer Stage 0 | Colorectal Cancer Stage IItaly
-
University of Southern CaliforniaNational Cancer Institute (NCI); AmgenTerminatedStage IV Colorectal Cancer AJCC v7 | Stage IVA Colorectal Cancer AJCC v7 | Stage IVB Colorectal Cancer AJCC v7 | Colorectal Adenocarcinoma | RAS Wild Type | Stage III Colorectal Cancer AJCC v7 | Stage IIIA Colorectal Cancer AJCC v7 | Stage IIIB Colorectal Cancer AJCC v7 | Stage IIIC Colorectal Cancer...United States
Clinical Trials on Stereotactic body radiotherapy
-
Mercy ResearchCompletedNasopharyngeal Carcinoma | Squamous Cell Carcinoma of the Head and Neck | Salivary Gland Cancer | Paraganglioma of Head and Neck | Head and Neck Sarcoma | Chordoma of Head and Neck | Chondrosarcoma of Head and Neck | Angiofibroma of Head and NeckUnited States
-
The Netherlands Cancer InstituteCompletedLung Cancer | Metastatic Lung CancerNetherlands, United States, Canada, Germany
-
University of FloridaDiaCarta, Inc.Terminated
-
European Organisation for Research and Treatment...UnknownNon-small Cell Lung Cancer Stage I | Non-small Cell Lung Cancer Stage IIGermany, Belgium, United Kingdom, Switzerland
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH)TerminatedNon-small-cell Lung CancerUnited States
-
Mayo ClinicActive, not recruitingProstate CancerUnited States
-
UMC UtrechtCompletedBone Metastases | Spinal MetastasesNetherlands
-
National Taiwan University HospitalUnknownMetastasis of Malignant Neoplasm to Lymph NodeTaiwan
-
Maria Sklodowska-Curie National Research Institute...RecruitingRadiotherapy | Local Recurrence of Malignant Tumor of ProstatePoland
-
Linda Chan, MDRecruiting