Head and Neck Squamous Cell CarcinomaPhase 1/2HNSCCNCT01280318
Profile of Plasma Growth Factors Before and After Head and Neck Oncological or Non-oncological Surgery
A Phase 1/2 study testing head and neck surgery in people with Head and Neck Squamous Cell Carcinoma and Growth Factor, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The obvious hypothesis is that the application of peri-operative targeted biological agents may counteract the tumor growth effect of these circulating factors and improve patient outcome Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma, Growth Factor, Surgery
- What is being tested?
- head and neck surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2009to Sep 2012
- Phase
- Phase 1/2
- 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
- Age 18 years and over
- histological proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharinx or larynx
- Patients selected for a primary surgical treatment
- no distant metastases
- no active second malignancy during the last 5 years except non melanoma skin cancer or carcinoma in situ of the cervix
- no prior or concurrent evidence of uncontrolled severe pathology precluding administration of surgery
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- life expectancy of more than 3 months
- not pregnant or nursing; fertile patients both male and female, must use effective contraception
- absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- signed informed consent
- performance status ECOG 0-1
Who cannot join
- Nasopharynx cancer
- past or current malignancy other than HNSCC
- performance ECOG status more than 2
- concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
- use of any investigational agents within 4 weeks prior to entry
- Previous exposure to EGFR targeting therapy
- known grade hypersensitivity to cetuximab
- legal incapacity or limited legal capacity or medical or psychological condition which in the opiniion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
The obvious hypothesis is that the application of peri-operative targeted biological agents may counteract the tumor growth effect of these circulating factors and improve patient outcome
- Being tested
- head and neck surgery
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
head and neck surgeryProcedure or surgery
Blood Sample of biomakers at 3 days, 5 weeks and 3 months after surgery.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | patients with operable head and neck squamous cell carcinoma Receives: Procedure: head and neck surgery |
| 2 | Other | patients treated by neck ansd head surgery for a non-oncological disease Receives: Procedure: head and neck surgery |
| 3 | Experimental | patients treated before surgery with 3 doses of neoadjuvant cetuximab Receives: Procedure: head and neck surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
identification of the biomarkers could lead to the development of peri-operative targeted therapies to decrease the risk of local and distant tumor growth
Measured: 5 months
Secondary outcomes (1)
Compare the results of group I with groups II and III
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2011 (estimated)
- Study startJan 2009
- Primary completionDec 2011
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Pascal Machiels, PhD, Principal investigator, Cliniques Universitaires St Luc-UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01280318
- Sponsor's protocol ID
- UCL-ONCO 2008-03
- Other IDs
- Academic study
- Acronym
- HNSCC
- Status last verified
- Nov 2012
- First submitted
- 19 Jan 2011
- Last updated
- 14 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Profile of Plasma Growth Factors Before and After Head and Neck Oncological or Non-oncological Surgery
- ClinicalTrials.gov ID
- NCT01280318
- Acronym / sponsor ID
- HNSCC / UCL-ONCO 2008-03
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 20 Jan 2011 (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 obvious hypothesis is that the application of peri-operative targeted biological agents may counteract the tumor growth effect of these circulating factors and improve patient outcome
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: head and neck surgerypatients with operable head and neck squamous cell carcinoma |
| 2 | Other | Procedure: head and neck surgerypatients treated by neck ansd head surgery for a non-oncological disease |
| 3 | Experimental | Procedure: head and neck surgerypatients treated before surgery with 3 doses of neoadjuvant cetuximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18 years and over
- histological proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharinx or larynx
- Patients selected for a primary surgical treatment
- no distant metastases
- no active second malignancy during the last 5 years except non melanoma skin cancer or carcinoma in situ of the cervix
Key exclusion criteria (8 listed)
- Nasopharynx cancer
- past or current malignancy other than HNSCC
- performance ECOG status more than 2
- concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
- use of any investigational agents within 4 weeks prior to entry
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 |
|---|---|---|
| head and neck surgeryBlood Sample of biomakers at 3 days, 5 weeks and 3 months after surgery. | Procedure or surgery | 1, 2, 3 |
Primary outcome
identification of the biomarkers could lead to the development of peri-operative targeted therapies to decrease the risk of local and distant tumor growth
Time frame: 5 months
1 secondary outcome
Compare the results of group I with groups II and III
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2012.
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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.
Jean-Pascal Machiels, PhD principal investigator
Cliniques Universitaires St Luc-UCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing head and neck surgery in people with Head and Neck Squamous Cell Carcinoma and Growth Factor, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 11 inclusion and 8 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 14 Nov 2012. 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 Belgium. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
identification of the biomarkers could lead to the development of peri-operative targeted therapies to decrease the risk of local and distant tumor growth (time frame: 5 months). 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 14 Nov 2012.