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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00042926
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 7, 2016
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Head and Neck Cancer Other: immunohistochemistry staining method Procedure: conventional surgery Procedure: lymphangiography Procedure: radionuclide imaging Procedure: sentinel lymph node biopsy Radiation: technetium Tc 99m sulfur colloid

Detailed Description:


  • 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 161 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Trial Of Lymphatic Mapping And Sentinel Node Lymphadenectomy For Patients With T1 or T2 Clinically N0 Oral Cavity Squamous Cell Carcinoma
Study Start Date : May 2002
Primary Completion Date : May 2007
Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oral Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Radiolymphoscintigraphy + 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.

Other: immunohistochemistry staining method Procedure: conventional surgery Procedure: lymphangiography Procedure: radionuclide imaging Procedure: sentinel lymph node biopsy Radiation: technetium Tc 99m sulfur colloid

Outcome Measures

Primary Outcome Measures :
  1. Proportion of non-SLN(s) negative patients [ Time Frame: Up to 30 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00042926

Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Francisco Civantos, MD University of Miami Sylvester Comprehensive Cancer Center
More Information

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00042926     History of Changes
Other Study ID Numbers: ACOSOG-Z0360
CDR0000069485 ( Registry Identifier: NCI Physician Data Query )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016

Keywords provided by Alliance for Clinical Trials in Oncology:
stage I squamous cell carcinoma of the lip and oral cavity
stage II squamous cell carcinoma of the lip and oral cavity

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Technetium Tc 99m Sulfur Colloid
Molecular Mechanisms of Pharmacological Action