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Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab?


N/A
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer Metastatic

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Trial Information

Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab?


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.

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Principal Investigator

Gil Bar-Sela, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rambam Health Care Campus

Authority:

Israel: Ethics Commission

Study ID:

B427CTIL

NCT ID:

NCT01382407

Start Date:

July 2011

Completion Date:

June 2013

Related Keywords:

  • Colorectal Cancer Metastatic
  • skin rash reaction
  • ERBITUX® (cetuximab)
  • acne
  • Colorectal Neoplasms
  • Neoplasms
  • Neoplasms, Second Primary

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