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 @ 5:16 PM
Ignite Modification Date:
2025-12-24 @ 5:16 PM
NCT ID:
NCT01864850
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 70 or over
* SIOG group 2 (vulnerable)
* Life expectancy \> 12 weeks
* PS \< 2
* Histologically confirmed diagnosis of squamous cell carcinoma of head and neck: oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, cervical nodes (unknown primary).
* First line treatment
* At least one measurable lesion (RECIST)
* Stage II to IV
* Patients unsuitable for surgery of the primary tumour: non resectable tumor, anesthesia contra indication, patient's refusal, or organ sparing approach. Cervical nodes dissection authorized
* Patients planned to be treated in a curative intent with radiotherapy alone on primary tumor site and on at least one head and neck node area
* Consent form signed
Exclusion Criteria:
* Primary squamous cell carcinoma of sinus, the skin or of the salivary glands
* Stage I cancer
* Radiotherapy planned on primary tumor only, or on neck nodes only. For patients with metastatic lymph nodes from unknown primary head and neck squamous cell carcinoma, patients will be excluded if head and neck mucosa (oropharynx, larynx, hypopharynx) is not included as a target volume for radiotherapy
* Prior radiotherapy of head and neck area
* Concurrent chemotherapy or immunotherapy or hormonotherapy
* Induction chemotherapy
* Concomitant infection requiring IV antibiotics
* cancer other than head and neck cancer within the previous 5 years (baso cellular skin carcinoma and cervix carcinoma excepted)
* conditions that could lead to bad compliance
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
70 Years
Study:
NCT01864850
Study Brief:
Protocol Section:
NCT01864850