Primary Esophageal CarcinomaEarly Phase 1NCT02072720
Angiogenic Factor Expression During Fractionated Irradiation
A Early Phase 1 study testing Bevacizumab in people with Primary Esophageal Carcinoma, run by Amsterdam UMC, location VUmc at 3 sites in Netherlands.
Trial summary
The main question of this study is if and when VEGF (vascular endothelial growth factor) expression in the tumor is upregulated during chemoradiation and if bevacizumab inhibits subsequent vessel growth in the tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Esophageal Carcinoma
- What is being tested?
- Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesNetherlands
- Study dates
- Feb 2014to 1 May 2021
- Phase
- Early Phase 1
- 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
- patients that will receive chemoradiation following CROSS-schedule before surgery for esophageal carcinoma
- ability to give informed consent
- age 18 years or older
Who cannot join
- pregnancy
- evidence of bleeding diathesis, coagulopathy
- inflammation of the GI-tract
- brain metastases
- diastolic/ systolic hypertension, not responding to treatment
- arterial thromboembolism in medical history
- surgery within the month prior to start of bevacizumab treatment
Trial locations and contacts
3 sites in 1 country.
Henk Verheul, MD/ PhD contact
Netherlands3 sites, 3 recruiting
- Recruiting
Noordwest Ziekenhuisgroep
Alkmaar
A. M. Van Berkel
- Recruiting
VU university medical center
Amsterdam, North Holland, 1081 HV
Henk Verheul, MD/PhD
- Recruiting
Academisch Medisch Centrum
Amsterdam
H. W.M. van Laarhoven
About this study
Official title: Pilot Study to Determine the Effect of Fractionated Radiotherapy on Expression of Pro-angiogenic Factors in Oesophagus Carcinoma
The main question of this study is if and when VEGF (vascular endothelial growth factor) expression in the tumor is upregulated during chemoradiation and if bevacizumab inhibits subsequent vessel growth in the tumor.
- Therefore the first aim of this study is to identify the time point of induction of VEGF in the tumor tissue of esophagus carcinoma during chemoradiation (after 1,2,3 or 4 weeks of chemoradiation).
- If we identify increased expression of VEGF at a certain time point, our second aim is to determine if we can inhibit the subsequent tumor vessel growth by administration of bevacizumab.
- Conditions
- Primary Esophageal Carcinoma
- Being tested
- Bevacizumab
- Keywords
- Radiotherapy, VEGF, esophagus carcinoma, bevacizumab
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Bevacizumab (Avastin).
patients will receive bevacizumab (3mg/kg/wk) starting from the identified induction time point of VEGF expression
| Study group | Role | What they receive |
|---|---|---|
| on-treatment tumor biopsie | No intervention | patients will undergo an pre-treatment and on-treatment tumor biopsy, to measure VEGF expression, and identify the time point of induction of VEGF expression. |
| bevacizumab | Experimental | These patients will receive bevacizumab once a week during their chemoradiation, starting at the identified time point of enhanced VEGF expression. These patients will also undergo and pre-treatment tumor biopsy and 1 tumor biopsy 1 week after the start of bevacizumab treatment. Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of VEGF mRNA expression in tumor biopsies
To compare the VEGF mRNA expression in the pre-treatment and on-treatment tumor biopsies, to measure the change in VEGF expression from baseline.
Measured: 5 weeks
Change of VEGFR2 phosphorylation with IHC
To determine the level of pVEGFR2 expression in tumor biopsies of patients that received bevacizumab, and to compare that to their pre-treatment expression levels, to identify the changes in expression from baseline.
Measured: 8 weeks
Secondary outcomes (3)
Changes of mRNA expression of other pro-angiogenic factors
To identify the expression of other pro-angiogenic factors in the tumor, and to measure the changes from baseline expression (pre-treatment vs on-treatment biopsies).
Measured: 5 weeks
Changes in protein expression of pro-angiogenic factors
To identify the protein expression of other pro-angiogenic factors in the tumor, and to measure the changes from baseline expression (pre-treatment vs on-treatment biopsies).
Measured: 5 weeks
Changes in vascular parameters in the tumor tissue to asses ongoing angiogenesis
To identify the expression of CD31+ and pericyte markers with IHC staining in the tumor, and to measure the changes from baseline expression (pre-treatment vs on-treatment biopsies).
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2021 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Esophageal CarcinomaStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Noordwest Ziekenhuisgroep, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Responsible party
- Principal investigator, H.M.W. Verheul, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02072720
- Sponsor's protocol ID
- 2013/340
- Status last verified
- Oct 2019
- First submitted
- 19 Feb 2014
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Determine the Effect of Fractionated Radiotherapy on Expression of Pro-angiogenic Factors in Oesophagus Carcinoma
- ClinicalTrials.gov ID
- NCT02072720
- Acronym / sponsor ID
- 2013/340
- Conditions
- Primary Esophageal Carcinoma
- Keywords
- Radiotherapy, VEGF, esophagus carcinoma, bevacizumab
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Noordwest Ziekenhuisgroep, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study start
- Feb 2014
- Primary completion
- Mar 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 26 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main question of this study is if and when VEGF (vascular endothelial growth factor) expression in the tumor is upregulated during chemoradiation and if bevacizumab inhibits subsequent vessel growth in the tumor.
- Therefore the first aim of this study is to identify the time point of induction of VEGF in the tumor tissue of esophagus carcinoma during chemoradiation (after 1,2,3 or 4 weeks of chemoradiation).
- If we identify increased expression of VEGF at a certain time point, our second aim is to determine if we can inhibit the subsequent tumor vessel growth by administration of bevacizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| on-treatment tumor biopsie | No intervention | –patients will undergo an pre-treatment and on-treatment tumor biopsy, to measure VEGF expression, and identify the time point of induction of VEGF expression. |
| bevacizumab | Experimental | Drug: BevacizumabThese patients will receive bevacizumab once a week during their chemoradiation, starting at the identified time point of enhanced VEGF expression. These patients will also undergo and pre-treatment tumor biopsy and 1 tumor biopsy 1 week after the start of bevacizumab treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients that will receive chemoradiation following CROSS-schedule before surgery for esophageal carcinoma
- ability to give informed consent
- age 18 years or older
Key exclusion criteria (7 listed)
- pregnancy
- evidence of bleeding diathesis, coagulopathy
- inflammation of the GI-tract
- brain metastases
- diastolic/ systolic hypertension, not responding to treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevacizumabAlso: Bevacizumab (Avastin).patients will receive bevacizumab (3mg/kg/wk) starting from the identified induction time point of VEGF expression | Drug | bevacizumab |
Primary outcome
Change of VEGF mRNA expression in tumor biopsies
Time frame: 5 weeks
To compare the VEGF mRNA expression in the pre-treatment and on-treatment tumor biopsies, to measure the change in VEGF expression from baseline.
Change of VEGFR2 phosphorylation with IHC
Time frame: 8 weeks
To determine the level of pVEGFR2 expression in tumor biopsies of patients that received bevacizumab, and to compare that to their pre-treatment expression levels, to identify the changes in expression from baseline.
3 secondary outcomes
Changes of mRNA expression of other pro-angiogenic factors
Time frame: 5 weeks
Changes in protein expression of pro-angiogenic factors
Time frame: 5 weeks
Changes in vascular parameters in the tumor tissue to asses ongoing angiogenesis
Time frame: 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henk Verheul, MD/ PhD contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Bevacizumab in people with Primary Esophageal Carcinoma, run by Amsterdam UMC, location VUmc at 3 sites in Netherlands.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Henk Verheul, MD/ PhD (h.verheul@vumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of VEGF mRNA expression in tumor biopsies (time frame: 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2019.