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Colorectal Cancer.Phase 2SBRT-AvastinNCT01569984

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

A Phase 2 study testing Stereotactic body radiotherapy in people with Colorectal Cancer., run by Dr. Yoo-Joung Ko at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer.
What is being tested?
Stereotactic body radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteCanada
Study dates
Mar 2012to Mar 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Stereotactic body radiotherapy
Keywords
Colorectal
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stereotactic body radiotherapyRadiation

    Also called Bevacizumab

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

Study groups in NCT01569984
Study groupRoleWhat they receive
Avastin, SBRTExperimental2 treatments of avastin followed by 6 treatments of SBRT every other day.
Receives: Radiation: Stereotactic body radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tumor perfusion

    Tumor perfusion as measured by DCE-CT

    Measured: day 24

Secondary outcomes (1)

  1. Blood flow

    Contrast Enhanced Ultrasound

    Measured: Day 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionMar 2015
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01569984
Sponsor's protocol ID
OZM-032
Acronym
SBRT-Avastin
Status last verified
Oct 2016
First submitted
30 Mar 2012
Last updated
13 Oct 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Stereotactic body radiotherapy in people with Colorectal Cancer., run by Dr. Yoo-Joung Ko at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumor perfusion (time frame: day 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01569984.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2016.

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