Head and Neck CancerNCT01075828
Prospective, Post Marketing Surveillance Study On Erbitux® (Cetuximab) in Patients With Locally Advanced or Recurrent and/or Metastatic Squamous Cell Cancer of the Head and Neck in Korea
An observational study of Head and Neck Cancer, run by Merck KGaA, Darmstadt, Germany at 1 site in South Korea.
Trial summary
After consultation with the Korean Health Authorities, the two Post-Authorization Safety Studies EMR 62202-509 (NCT01082315) and EMR 62241-508 (NCT01075828) were combined within one study protocol EMR 062202-551. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Cetuximab
- How many people
- 221 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2009to Jul 2014
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects with locally advanced or recurrent and/or metastatic SCCHN eligible for Erbitux treatment will be enrolled in the study.
Who may be able to join
- Subjects who are eligible for Erbitux treatment according to the indication in the national label of Erbitux. The national label approved by Korea Food \& Drug Administration is "Erbitux in combination with radiation therapy is indicated for the treatment of subjects with locally advanced or recurrent and/or metastatic SCCHN
Who cannot join
- Subjects who are not eligible for Erbitux treatment according to the indication in the national label of Erbitux
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chungnam National University Hospital
Jung-gu Daejeon, 301-721
About this study
Official title: A Korean Post Marketing Surveillance Study On Erbitux® (Cetuximab) In Patients With Locally Advanced or Recurrent and/or Metastatic Squamous Cell Cancer of the Head and Neck (SCCHN)
After consultation with the Korean Health Authorities, the two Post-Authorization Safety Studies EMR 62202-509 (NCT01082315) and EMR 62241-508 (NCT01075828) were combined within one study protocol EMR 062202-551. This Post-Marketing Surveillance Study (PMS) EMR 062202-551 is requested by the Korean Health Authorities to continue monitoring of Erbitux and provide further information about safety and toxicity in clinical practice in at least 900 patients during 6 years.
All data points from the EMR 62202-509 (NCT01082315) and EMR 62241-508 (NCT01075828) remain unchanged in protocol EMR 062202-551. Therefore, the Sponsor has decided not to separately disclose the EMR 062202-551 study titled "A Korean Post-Marketing Surveillance Study On Erbitux® (Cetuximab) in Patients With Locally Advanced or Recurrent and/or Metastatic Squamous Cell Cancer of the Head and Neck (originally EMR 62241-508) and in Patients With EGFR-expressing, KRAS wild-type Metastatic Colorectal Cancer (originally EMR 62202-509)" on clinicaltrials.gov.
Read the detailed description
This is a prospective, Post Marketing Surveillance (PMS) study on Erbitux® (Cetuximab) in patients with locally advanced or recurrent and/or metastatic squamous cell cancer of the head and neck in Korea
This prospective study will collect safety information from more than 300 subjects treated with Erbitux as final evaluable cases. During the PMS period, subject background, subject's medical (surgery, anti-cancer treatment) history, Erbitux treatment status, concurrent medication, response evaluation, status and reason of discontinuation, all adverse events (AEs; regardless of the causal relationship to Erbitux), and abnormal results of laboratory tests will be collected for the study purpose.
The PMS is based on all cases treated with Erbitux at least once. The PMS will be done within 6 years from the approval date of the new indication. This PMS is requested by the Korean Regulatory Authorities. After approval of new indication in Korea, it is further required to investigate more than 300 subjects during 6 years according to local regulations to continue monitoring and provide further information about safety and toxicity in clinical practice.
OBJECTIVES Analysis on safety and efficacy information on the use of Erbitux in the market and factors affecting its safety and efficacy.
Primary objective:
- To obtain safety information on the use of Erbitux in subjects with locally advanced SCCHN or recurrent and/or metastatic in terms of frequency and severity of AEs
Secondary objectives:
- To gather clinical efficacy information of the treatment
- Conditions
- Head and Neck Cancer
- Being tested
- Cetuximab
- Keywords
- Head and Neck Neoplasms, Neoplasms, Squamous Cell, Cetuximab
- Medical subject headings
- Head and Neck Neoplasms, Neoplasms, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
Also called Erbitux
Subjects will be treated according to the national label of cetuximab in combination with radiation therapy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Adverse Events
The frequency and severity of all adverse events, regardless of the causal relationship to Erbitux, will be measured within 6 years of the observational period from the approval date of the new indication
Measured: 6 years
Secondary outcomes (1)
Clinical efficacy
The duration of control of locoregional disease, 1-year/2-year/3-year locoregional control rate, best tumor response will be measured within the observational period from the approval date of the new indication
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2010 (estimated)
- Study startMar 2009
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01075828
- Sponsor's protocol ID
- EMR62241-508 (EMR 62202-551)
- Status last verified
- Aug 2014
- First submitted
- 24 Feb 2010
- Last updated
- 29 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Korean Post Marketing Surveillance Study On Erbitux® (Cetuximab) In Patients With Locally Advanced or Recurrent and/or Metastatic Squamous Cell Cancer of the Head and Neck (SCCHN)
- ClinicalTrials.gov ID
- NCT01075828
- Acronym / sponsor ID
- EMR62241-508 (EMR 62202-551)
- Conditions
- Head and Neck Cancer
- Keywords
- Head and Neck Neoplasms, Neoplasms, Squamous Cell, Cetuximab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 25 Feb 2010 (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.
After consultation with the Korean Health Authorities, the two Post-Authorization Safety Studies EMR 62202-509 (NCT01082315) and EMR 62241-508 (NCT01075828) were combined within one study protocol EMR 062202-551. This Post-Marketing Surveillance Study (PMS) EMR 062202-551 is requested by the Korean Health Authorities to continue monitoring of Erbitux and provide further information about safety and toxicity in clinical practice in at least 900 patients during 6 years.
All data points from the EMR 62202-509 (NCT01082315) and EMR 62241-508 (NCT01075828) remain unchanged in protocol EMR 062202-551. Therefore, the Sponsor has decided not to separately disclose the EMR 062202-551 study titled "A Korean Post-Marketing Surveillance Study On Erbitux® (Cetuximab) in Patients With Locally Advanced or Recurrent and/or Metastatic Squamous Cell Cancer of the Head and Neck (originally EMR 62241-508) and in Patients With EGFR-expressing, KRAS wild-type Metastatic Colorectal Cancer (originally EMR 62202-509)" on clinicaltrials.gov.
Detailed description
This is a prospective, Post Marketing Surveillance (PMS) study on Erbitux® (Cetuximab) in patients with locally advanced or recurrent and/or metastatic squamous cell cancer of the head and neck in Korea
This prospective study will collect safety information from more than 300 subjects treated with Erbitux as final evaluable cases. During the PMS period, subject background, subject's medical (surgery, anti-cancer treatment) history, Erbitux treatment status, concurrent medication, response evaluation, status and reason of discontinuation, all adverse events (AEs; regardless of the causal relationship to Erbitux), and abnormal results of laboratory tests will be collected for the study purpose.
The PMS is based on all cases treated with Erbitux at least once. The PMS will be done within 6 years from the approval date of the new indication. This PMS is requested by the Korean Regulatory Authorities. After approval of new indication in Korea, it is further required to investigate more than 300 subjects during 6 years according to local regulations to continue monitoring and provide further information about safety and toxicity in clinical practice.
OBJECTIVES Analysis on safety and efficacy information on the use of Erbitux in the market and factors affecting its safety and efficacy.
Primary objective:
- To obtain safety information on the use of Erbitux in subjects with locally advanced SCCHN or recurrent and/or metastatic in terms of frequency and severity of AEs
Secondary objectives:
- To gather clinical efficacy information of the treatment
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with locally advanced or recurrent and/or metastatic SCCHN eligible for Erbitux treatment will be enrolled in the study.
Key inclusion criteria (1 listed)
- Subjects who are eligible for Erbitux treatment according to the indication in the national label of Erbitux. The national label approved by Korea Food \& Drug Administration is "Erbitux in combination with radiation therapy is indicated for the treatment of subjects with locally advanced or recurrent and/or metastatic SCCHN
Key exclusion criteria (1 listed)
- Subjects who are not eligible for Erbitux treatment according to the indication in the national label of Erbitux
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 |
|---|---|---|
| CetuximabAlso: ErbituxSubjects will be treated according to the national label of cetuximab in combination with radiation therapy. | Drug | – |
Primary outcome
Frequency of Adverse Events
Time frame: 6 years
The frequency and severity of all adverse events, regardless of the causal relationship to Erbitux, will be measured within 6 years of the observational period from the approval date of the new indication
1 secondary outcome
Clinical efficacy
Time frame: 6 years
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 29 Aug 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by Merck KGaA, Darmstadt, Germany at 1 site in South Korea.
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 1 inclusion and 1 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 29 Aug 2014. 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 South Korea. 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.
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?
Frequency of Adverse Events (time frame: 6 years). 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 29 Aug 2014.