Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-25 @ 5:00 AM
NCT ID:
NCT01280318
Eligibility Criteria:
Inclusion Criteria:
* 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
* 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
Exclusion Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01280318
Study Brief:
Protocol Section:
NCT01280318