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 @ 9:28 PM
Ignite Modification Date:
2025-12-24 @ 9:28 PM
NCT ID:
NCT00540332
Eligibility Criteria:
Inclusion Criteria:
* History of newly diagnosed histologically confirmed squamous cell carcinoma (AJCC Stage II, III or IVA) involving either the oral cavity, oropharynx, hypopharynx, larynx and post surgical resection (R0 or R1)
* Candidates for postoperative RT-only treatment and scheduled to receive RT within 12 weeks of surgery
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
* Urinary protein-creatinine ratio (random sample, spot PCR) ≤ 0.2 mg/mg
Exclusion Criteria:
* Tumors of the lips, paranasal sinuses, salivary glands, or of unknown primary tumors and R2 resection margins
* Metastatic disease (M1)
* Presence or history of any other primary malignancy, other than curatively treated in situ cervical cancer, or basal cell carcinoma of the skin without evidence of disease for \> 3 years
* History of pancreatitis
* Prior radiotherapy to the site of disease
* Prior chemotherapy or requiring chemotherapy during treatment phase of study
* Prior treatment with palifermin, or other fibroblast or keratinocyte growth factors
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00540332
Study Brief:
Protocol Section:
NCT00540332