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 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT00147732
Eligibility Criteria:
Inclusion Criteria:
* Pathological confirmed squamous cell carcinoma of the larynx.
* TNM-classification (UICC 1997, appendix I):
* T3-4 glottic or supraglottic carcinoma
* T2 glottic carcinoma with impaired cord mobility or subglottic extension
* T2 supraglottic carcinoma with invasion of mucosa of base of tongue or vallecula or invasion of the medial wall of the piriform sinus.
* any N-stage, M0.
* WHO performance status 0 or 1 (appendix II).
* Age \> 18 years.
* Written informed consent.
* Quality of life questionnaire completed.
Exclusion Criteria:
* Prior or concurrent treatment for this tumour.
* Severe stridor and adequate debulking of airway not possible.
* Impaired renal function: serum creatinine above upper normal limit.
* Use of nefrotoxic medication (including ACE-inhibitors) that cannot be discontinued for the duration of the radiation treatment.
* Impaired hepatic function: ASAT and ALAT more than 1.5 times the upper normal limit.
* Use of anti-convulsants that cannot be discontinued for the duration of the radiation treatment.
* History of malignancy during the previous 5 years except basal cell carcinoma of skin, carcinoma in situ of the cervix, or superficial bladder neoplasm (pTa).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT00147732
Study Brief:
Protocol Section:
NCT00147732