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 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT00756951
Eligibility Criteria:
Inclusion Criteria:
* Subject must have a body weight less than 150 kg at screening
* Have recently-diagnosed, pathologically-confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx that will be treated with chemoradiation therapy as first line treatment(postoperative patients are eligible, if surgery is \< 6 weeks prior to initiation of radiotherapy.
* Plan to receive a continuous course of conventional external beam irradiation
* Plan to receive a standard cisplatin chemotherapy regimen
Exclusion Criteria:
* Pregnant or breastfeeding
* Have head and neck tumors of the lips, sinuses, salivary glands or unknown primary tumor
* Prior radiation to the head and neck
* Have a plan to receive cetuximab (Erbitux) in conjunction with chemotherapy
* Had curative surgery more than 6 weeks prior to the initiation of radiotherapy
* Have current oral mucositis
* Presence of active infectious disease excluding oral candidiasis
* Chronic immunosuppression
* Seropositive for HIV or hepatitis B surface antigen or C antibody
* Used an investigational agent within 30 days of randomization
* Have a known sensitivity to any investigational agent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00756951
Study Brief:
Protocol Section:
NCT00756951