Diagnostic Trial in Patients Who Are Undergoing Surgery for Early Stage Mouth Cancer
- Conditions
- Head and Neck Cancer
- Registration Number
- NCT00042926
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Diagnostic procedures to detect cancer cells in sentinel lymph nodes may help plan effective cancer treatment.
PURPOSE: Diagnostic trial to study the effectiveness of lymph node mapping and sentinel lymph node lymphadenectomy in patients who are undergoing surgery to remove early-stage cancer of the mouth.
- Detailed Description
OBJECTIVES:
* Determine whether a negative hematoxylin and eosin finding from the lymphatic mapping and sentinel node lymphadenectomy procedure accurately predicts the negativity of the other cervical lymph nodes in patients with stage I or II squamous cell carcinoma of the oral cavity.
* Determine the extent and pattern of disease spread in the nodal bed in these patients.
* Obtain data on the use of immunohistochemistry to assess nodes in these patients.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 161
-
Patient must be > 18 years of age.
-
Patient must have an ECOG/Zubrod performance status of < 2.
-
Patient must have a histologically confirmed primary T1 or T2 invasive OCSCCA that is > 6mm and < 4 cm in size. The primary tumor must be amenable to curative resection and must be diagnosed within 42 days prior to surgery.
-
Patient must be clinically stage N0 confirmed with a negative imaging study employing contrastenhanced CT scan (or MRI with gadolinium in patients with iodine allergy). Lymph nodes will be considered positive if:
- Greater than 1.5 cm in size for levels I and II.
- Greater than 1 cm in size for levels III, IV, V and VI.
- If any lymph node exhibits central necrosis, irregular enhancement of a poorly defined or irregular capsular border.
- Groups of three or more asymmetrically located LNs, with a minimal axial diameter of 8 mm or more, in the suspected tumor drainage area are present.
- NOTE: All CT scans must be read by a neuroradiologist.
-
Patient must be medically fit for neck dissection.
-
Patient or the patient's legally acceptable representative must provide a signed and dated written informed consent prior to registration or any study-related procedures.
-
Female patient of childbearing potential must have negative serum pregnancy test within 30 daysprior to registration.
-
If the patient is a survivor of a prior cancer, ALL of the following criteria are met:
- Patient has undergone potentially curative therapy for all prior malignancies,
- No evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for effectively treated basal cell or squamous carcinoma of the skin, carcinoma in-situ of the cervix that has been effectively treated by surgery alone, or lobular carcinoma in-situ of the ipsilateral or contralateral breast treated by surgery alone),
- Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.
- Patient received prior treatment to the cervical lymph nodes, including surgery or radiation therapy.
- Patient experienced prior extensive trauma to the anterior cervical region of the neck.
- Patient has lesions that cross the vermilion border involving lip skin.
- Patient has had previous tumor resection involving the neck.
- Patient has had injections of radioactive material for previous scans within 48 hours of the radiolymphoscintigraphy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Proportion of non-SLN(s) negative patients Up to 30 days
- Secondary Outcome Measures
Name Time Method