Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab
This trial is active, not recruiting.
|Condition||colorectal cancer metastatic|
|Sponsor||Rambam Health Care Campus|
|Start date||July 2011|
|End date||March 2016|
|Trial size||100 participants|
|Trial identifier||NCT01382407, B427CTIL|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Observational model||case control|
Relationship between acne and skin rash
time frame: Within Erbitux treatment period (upto 12 months)
Male or female participants at least 18 years old.
Inclusion Criteria: - 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. Exclusion Criteria: - 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.
|Official title||Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab?|
|Principal investigator||Gil Bar-Sela, M.D.|
|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|
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