Diagnostic Trial in Patients Who Are Undergoing Surgery for Early Stage Mouth Cancer

Not Applicable

Completed

• Conditions: Head and Neck Cancer
• Interventions: Other: immunohistochemistry staining method; Procedure: conventional surgery; Procedure: lymphangiography; Procedure: radionuclide imaging; Procedure: sentinel lymph node biopsy; Radiation: technetium Tc 99m sulfur colloid

• 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.

Study Timeline

• Study Start: 2002-05
• Study First Submitted: 2002-08-05
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2007-05
• Study Completion: 2010-11
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-05
• Last Update Posted: 2016-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

Inclusion Criteria

1. Patient must be > 18 years of age.

2. Patient must have an ECOG/Zubrod performance status of < 2.

3. 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.

4. 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.

5. Patient must be medically fit for neck dissection.

6. 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.

7. Female patient of childbearing potential must have negative serum pregnancy test within 30 daysprior to registration.

8. If the patient is a survivor of a prior cancer, ALL of the following criteria are met:

   1. Patient has undergone potentially curative therapy for all prior malignancies,
   2. 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),
   3. Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.

Exclusion Criteria

1. Patient received prior treatment to the cervical lymph nodes, including surgery or radiation therapy.
2. Patient experienced prior extensive trauma to the anterior cervical region of the neck.
3. Patient has lesions that cross the vermilion border involving lip skin.
4. Patient has had previous tumor resection involving the neck.
5. 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

Arm && Interventions

Group	Intervention	Description
Radiolymphoscintigraphy + surgery	lymphangiography	Patients undergo radiolymphoscintigraphy comprising technetium Tc 99m sulfur colloid to identify the sentinel lymph nodes (SNL). Within 18 hours after radiolymphoscintigraphy, patients undergo resection of the primary oral cavity tumor and radioguided sentinel lymphadenectomy and regional cervical lymphadenectomy. Lymph nodes are examined by hematoxylin and eosin (H\&E) staining. If negative by H\&E, lymph nodes are further analyzed by immunohistochemistry. Patients are followed at 30 days.
Radiolymphoscintigraphy + surgery	radionuclide imaging	Patients undergo radiolymphoscintigraphy comprising technetium Tc 99m sulfur colloid to identify the sentinel lymph nodes (SNL). Within 18 hours after radiolymphoscintigraphy, patients undergo resection of the primary oral cavity tumor and radioguided sentinel lymphadenectomy and regional cervical lymphadenectomy. Lymph nodes are examined by hematoxylin and eosin (H\&E) staining. If negative by H\&E, lymph nodes are further analyzed by immunohistochemistry. Patients are followed at 30 days.
Radiolymphoscintigraphy + surgery	conventional surgery	Patients undergo radiolymphoscintigraphy comprising technetium Tc 99m sulfur colloid to identify the sentinel lymph nodes (SNL). Within 18 hours after radiolymphoscintigraphy, patients undergo resection of the primary oral cavity tumor and radioguided sentinel lymphadenectomy and regional cervical lymphadenectomy. Lymph nodes are examined by hematoxylin and eosin (H\&E) staining. If negative by H\&E, lymph nodes are further analyzed by immunohistochemistry. Patients are followed at 30 days.
Radiolymphoscintigraphy + surgery	technetium Tc 99m sulfur colloid	Patients undergo radiolymphoscintigraphy comprising technetium Tc 99m sulfur colloid to identify the sentinel lymph nodes (SNL). Within 18 hours after radiolymphoscintigraphy, patients undergo resection of the primary oral cavity tumor and radioguided sentinel lymphadenectomy and regional cervical lymphadenectomy. Lymph nodes are examined by hematoxylin and eosin (H\&E) staining. If negative by H\&E, lymph nodes are further analyzed by immunohistochemistry. Patients are followed at 30 days.
Radiolymphoscintigraphy + surgery	immunohistochemistry staining method	Patients undergo radiolymphoscintigraphy comprising technetium Tc 99m sulfur colloid to identify the sentinel lymph nodes (SNL). Within 18 hours after radiolymphoscintigraphy, patients undergo resection of the primary oral cavity tumor and radioguided sentinel lymphadenectomy and regional cervical lymphadenectomy. Lymph nodes are examined by hematoxylin and eosin (H\&E) staining. If negative by H\&E, lymph nodes are further analyzed by immunohistochemistry. Patients are followed at 30 days.
Radiolymphoscintigraphy + surgery	sentinel lymph node biopsy	Patients undergo radiolymphoscintigraphy comprising technetium Tc 99m sulfur colloid to identify the sentinel lymph nodes (SNL). Within 18 hours after radiolymphoscintigraphy, patients undergo resection of the primary oral cavity tumor and radioguided sentinel lymphadenectomy and regional cervical lymphadenectomy. Lymph nodes are examined by hematoxylin and eosin (H\&E) staining. If negative by H\&E, lymph nodes are further analyzed by immunohistochemistry. Patients are followed at 30 days.

Primary Outcome Measures

Name	Time	Method
Proportion of non-SLN(s) negative patients	Up to 30 days