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 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT01312493
Eligibility Criteria:
Inclusion Criteria:
* Histologically proven primary squamous cell carcinoma arising in the oral cavity, oropharynx, hypopharynx, or larynx.
* Stage III, IVA, or IVB disease (locally advanced with no systemic metastases and without bilateral nodal disease, i.e., N2c).
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2 with a life expectancy \>12 months.
* Patients are eligible if they have concurrent medical conditions that render them poor candidates for chemotherapy. Patients are considered to be in this group if any of the following criteria is met: Serum creatinine \>1.5 mg/dl (or estimated creatinine clearance \<50mL/min); Insulin dependent diabetes; SGOT, SGPT, or alkaline phosphatase \>2.5 x upper limit of normal; History of significant CAD (myocardial infarction \[MI\], coronary artery bypass graft \[CABG\], coronary stents, symptomatic angina); Congestive heart failure \[CHF\] (LVEF \<40% by echocardiogram or MUGA); nephropathy; Prior history of malignancy treated with chemotherapy; Severe chronic obstructive pulmonary disease \[COPD\], defined as FEV1 \<1L; In the opinion of the treating physician, patient would not tolerate the administration of concurrent chemotherapy and radiation
* Age \>18 years.
* The patient is medically fit to tolerate a course of definitive RT.
* The patient has adequate hematologic function defined as: absolute neutrophil count \>1000/ml, hematocrit \>24%, and platelet count \>50,000/ml. Patients with hematocrit between 20% and 24% should undergo transfusion, and may be enrolled provided their hematocrit reaches \>24%.
* The patient may have had a prior malignancy but must be disease-free for three years prior to study entry. A history of superficial non-melanoma skin cancer or in situ carcinoma of the cervix less than three years will be allowed.
* The patient must agree to use effective contraception if childbearing potential exists and continue contraception for at least 6 months following completion of the study.
* Evaluation by dental services prior to initiation of radiation therapy.
* Patient must be informed of the investigational nature of the study and sign an informed consent form.
Exclusion Criteria:
* The patient has received radiation therapy previously to the head and neck. NOTE: Previous radiotherapy for skin cancers of the head and neck are permitted if the fields do not overlap significantly.
* All gross disease has been surgically resected. NOTE: Patients who have had an excisional neck biopsy will not be eligible.
* Patient with positive contralateral neck node whether ipsilateral neck is negative or positive.
* The patient is pregnant or lactating.
* Squamous cell carcinoma arising in the nasopharynx, sinuses, salivary glands, or the primary is unknown.
* Non-squamous histologies (such as adenoid cystic or mucoepidermoid carcinoma).
* Spindle cell squamous carcinoma or mixed carcinoma/sarcoma.
* Scleroderma or active connective tissue disorder (Lupus).
* Any underlying psychological condition that would prohibit the understanding and rendering of informed consent.
* Major surgery \<3 weeks prior to study entry.
* History of interstitial lung disease, e.g., pulmonary fibrosis or interstitial pneumonitis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01312493
Study Brief:
Protocol Section:
NCT01312493