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 @ 2:19 AM
Ignite Modification Date:
2025-12-25 @ 2:19 AM
NCT ID:
NCT00004234
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, pharynx (oropharynx, hypopharynx, or nasopharynx), or larynx eligible for radical radiotherapy
* TX, T1-4, NX, N0-3, M0
* Directly visible area of mucosa including 2 or more protocol specified anatomical locations in the radical target volume
* At least 6 cm\^2 in area irrespective of shape
* No M1 disease
* Intention to deliver radiotherapy to a radical dose without chemotherapy
* May have had surgical resection of the primary or neck nodes
* Postoperative macroscopic or microscopic residual disease that is eligible for radical radiotherapy is allowed
* Patients with completely resected disease who are judged to be at high risk of relapse and who are eligible for radical radiotherapy are allowed
PATIENT CHARACTERISTICS:
Age:
* 16 and over
Performance status:
* ECOG 0-1
Life expectancy:
* Not specified
Hematopoietic:
* Hemoglobin ≥ 10 g/dL
* Granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* HIV negative
* Must have normal sleeping habits (i.e., normal circadian rhythm)
* Must have had dental assessment and necessary prophylactic dental extractions carried out
* No connective tissue diseases (e.g., systemic lupus, scleroderma, mixed connective tissue disease, rheumatoid arthritis)
* No organic brain syndrome related to chronic alcohol excess or other cause of sufficient severity that would preclude cooperation with treatment
* No active uncontrolled infection
* No history of psychiatric or neurological disorder that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* See Disease Characteristics
* At least 6 months since prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* See Disease Characteristics
* No prior radiotherapy to the head and neck region
Surgery:
* See Disease Characteristics
Other:
* No other concurrent oral hygiene regimen other than that described in the protocol
* No concurrent radioprotective drugs or therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
120 Years
Study:
NCT00004234
Study Brief:
Protocol Section:
NCT00004234