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 @ 11:19 PM
Ignite Modification Date:
2025-12-24 @ 11:19 PM
NCT ID:
NCT00003856
Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed recurrent, refractory, or second primary squamous cell cancer of the head and neck that is incurable with surgery or radiotherapy Any N, Any M, single or multiple tumor(s) Locally accessible, discrete tumor(s) by CT or MRI scan Must be considered incurable with surgery or radiotherapy, for example: Distant disease (e.g., lung and/or liver metastases) OR Cervical disease fixed to surrounding structures (e.g., carotid artery or prevertebral fascia) OR Metastases in the site of prior radiotherapy OR Not suitable for anesthesia or reconstructive surgery OR Multiple cutaneous metastases
PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No disease exacerbated by light, including systemic lupus erythematosus, psoriasis, porphyria, actinic reticuloid, or xeroderma pigmentosum Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 30 days since prior chemotherapy (6 weeks since nitrosoureas) Endocrine therapy: Concurrent steroid therapy allowed Radiotherapy: At least 30 days since prior radiotherapy to the head and neck Surgery: At least 30 days since prior surgery and recovered Other: At least 30 days since prior light activated therapy or medication (e.g.,PUVA or Accutane) No prior photodynamic therapy At least 30 days since prior experimental drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00003856
Study Brief:
Protocol Section:
NCT00003856