Colorectal Cancer MetastaticNCT01382407
Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab
An observational study of Colorectal Cancer Metastatic, run by Rambam Health Care Campus at 2 sites in Israel.
Trial summary
The hypothesis of this study is that patients who suffered from acne vulgaris during adolescence are at greater risk of developing acneiform skin rash due to cetuximab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic
- What is being tested?
- Cetuximab
- How many people
- 100 participants
- Where
- 2 sitesIsrael
- Study dates
- Jul 2011to 1 Apr 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients above the age of 18 years, who have been diagnosed with confirmed KRAS-WT mCRC, and are starting treatment with cetuximab, will be informed of the study.
Who may be able to join
- Age above 18 years.
- Histology or cytology proven KRAS-WT mCRC.
- Performance status ≤3 (Eastern Cooperative Oncology Group [ECOG] classification)
- Life expectancy of more than 12 weeks.
- Written informed consent.
- In women of childbearing potential, appropriate contraceptive measures must be used during treatment with cetuximab and for 6 months following the last dose of cetuximab.
Who cannot join
- Past systemic immune therapy for disease other than cancer.
- Past immune or other target therapy for cancer (not including bevacizumab).
- Presence of acne or acneiform rash prior to starting treatment with cetuximab.
- Patients with treatment plan of cetuximab and capecitabine combination.
- For female patients: the patient is pregnant or lactating.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Oncology Institute, Rambam Health Care Campus
Haifa, 31096
Rambam Health Care Campus
Haifa, 31096
About this study
Official title: Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab?
The hypothesis of this study is that patients who suffered from acne vulgaris during adolescence are at greater risk of developing acneiform skin rash due to cetuximab.
Read the detailed description
The hypothesis of this study is that patients who suffered from acne vulgaris during adolescence are at greater risk of developing acneiform skin rash due to cetuximab
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- Cetuximab
- Keywords
- skin rash reaction, ERBITUX® (cetuximab), acne
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
Also called Erbitux
Once a week:Loading dose-400 mg/m2;subsequent-250 mg/m2 on days 8,15, 22,29,36 if administered as a single agent, or together with Irinotecan 125 mg/m2 on days 1,8,15,29 followed by administration every 42 days.
| Study group | Role | What they receive |
|---|---|---|
| Cetuximab | All patients who started treatment with ERBITUX® (cetuximab), as a single agent or in combination with chemotherapy. Receives: Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between acne and skin rash
To determine whether there is a relationship between acne during adolescence and skin rash during cetuximab treatment?
Measured: Within Erbitux treatment period (upto 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJul 2011
- Primary completion1 Apr 2017
- Study completion1 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
- Investigators
- Gil Bar-Sela, M.D., Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01382407
- Sponsor's protocol ID
- B427CTIL
- Status last verified
- Apr 2017
- First submitted
- 23 Jun 2011
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab?
- ClinicalTrials.gov ID
- NCT01382407
- Acronym / sponsor ID
- B427CTIL
- Conditions
- Colorectal Cancer Metastatic
- Keywords
- skin rash reaction, ERBITUX® (cetuximab), acne
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Study start
- Jul 2011
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 27 Jun 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 hypothesis of this study is that patients who suffered from acne vulgaris during adolescence are at greater risk of developing acneiform skin rash due to cetuximab.
Detailed description
The hypothesis of this study is that patients who suffered from acne vulgaris during adolescence are at greater risk of developing acneiform skin rash due to cetuximab
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cetuximab | – | Drug: CetuximabAll patients who started treatment with ERBITUX® (cetuximab), as a single agent or in combination with chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients above the age of 18 years, who have been diagnosed with confirmed KRAS-WT mCRC, and are starting treatment with cetuximab, will be informed of the study.
Key inclusion criteria (6 listed)
- Age above 18 years.
- Histology or cytology proven KRAS-WT mCRC.
- Performance status ≤3 (Eastern Cooperative Oncology Group [ECOG] classification)
- Life expectancy of more than 12 weeks.
- Written informed consent.
Key exclusion criteria (5 listed)
- Past systemic immune therapy for disease other than cancer.
- Past immune or other target therapy for cancer (not including bevacizumab).
- Presence of acne or acneiform rash prior to starting treatment with cetuximab.
- Patients with treatment plan of cetuximab and capecitabine combination.
- For female patients: the patient is pregnant or lactating.
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: ErbituxOnce a week:Loading dose-400 mg/m2;subsequent-250 mg/m2 on days 8,15, 22,29,36 if administered as a single agent, or together with Irinotecan 125 mg/m2 on days 1,8,15,29 followed by administration every 42 days. | Drug | Cetuximab |
Primary outcome
Relationship between acne and skin rash
Time frame: Within Erbitux treatment period (upto 12 months)
To determine whether there is a relationship between acne during adolescence and skin rash during cetuximab treatment?
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 27 Apr 2017.
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CRC
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.
Gil Bar-Sela, M.D. principal investigator
Rambam Health Care Campus
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer Metastatic, run by Rambam Health Care Campus at 2 sites in Israel.
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 6 inclusion and 5 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 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
Relationship between acne and skin rash (time frame: Within Erbitux treatment period (upto 12 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 27 Apr 2017.