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:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-24 @ 10:34 PM
NCT ID:
NCT01341535
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed squamous cell carcinoma of oral cavity, oropharynx, hypopharynx or larynx
* Primary unresectable tumor and/or patients that refused surgery
* Stages T1-4; T3-4 N0 or T(any) N1-3 for glottic cancer
* Multidisciplinary decision of curative radiotherapy or radiochemotherapy
* Karnofsky performance status \>= 70 %
* Age \>= 18 years old
* Informed consent obtained, signed and dated before specific protocol procedures
Exclusion Criteria:
* High risk Human Papilloma Virus (HPV)
* Treatment combined with brachytherapy
* Prior irradiation to the head and neck region
* History of prior malignancies, except for cured non-melanoma skin cancer, curatively treated in-situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years.
* Distant metastases
* Pregnant or lactating women
* Creatinine clearance (Cockcroft-Gault) =\< 60 mL/min
* Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
* Patient unlikely to comply with protocol, i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01341535
Study Brief:
Protocol Section:
NCT01341535