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

This study has been completed.
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
First received: August 5, 2002
Last updated: November 24, 2010
Last verified: March 2006

August 5, 2002
November 24, 2010
May 2002
November 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00042926 on ClinicalTrials.gov Archive Site
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Diagnostic Trial in Patients Who Are Undergoing Surgery for Early Stage Mouth Cancer
A Trial Of Lymphatic Mapping And Sentinel Node Lymphadenectomy For Patients With T1 Or T2 Clinically N0 Oral Cavity Squamous Cell Carcinoma

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.


  • 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.

OUTLINE: This is a multicenter study.

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.

PROJECTED ACCRUAL: A total of 161 patients will be accrued for this study within 2.7 years.

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Masking: Open Label
Primary Purpose: Diagnostic
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
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Civantos FJ, Zitsch RP, Schuller DE, Agrawal A, Smith RB, Nason R, Petruzelli G, Gourin CG, Wong RJ, Ferris RL, El Naggar A, Ridge JA, Paniello RC, Owzar K, McCall L, Chepeha DB, Yarbrough WG, Myers JN. Sentinel lymph node biopsy accurately stages the regional lymph nodes for T1-T2 oral squamous cell carcinomas: results of a prospective multi-institutional trial. J Clin Oncol. 2010 Mar 10;28(8):1395-400. doi: 10.1200/JCO.2008.20.8777. Epub 2010 Feb 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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November 2010   (final data collection date for primary outcome measure)


  • Histologically confirmed primary invasive squamous cell carcinoma of the oral cavity

    • T1 or T2 disease
    • At least 6 mm and no greater than 4 cm in size
    • Amenable to curative resection
    • Diagnosed within 60 days prior to surgery
  • Clinical stage N0 confirmed by negative result from contrast-enhanced CT scan or gadolinium-enhanced MRI

    • Lymph nodes considered positive if:

      • Greater than 1.5 cm for levels I and II
      • Greater than 1 cm for levels III, IV, V, and VI
      • Any lymph node exhibits central necrosis or irregular enhancement of a poorly defined or irregular capsular border OR
      • Groups of 3 or more asymmetrically located lymph nodes, with a minimal axial diameter of 8 mm or more, are present in the suspected tumor drainage area
  • No oral malignancy crossing the vermilion border involving the lip skin



  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Zubrod 0-2

Life expectancy

  • Not specified


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  • No prior extensive trauma to the anterior cervical region of the neck
  • Medically fit for neck dissection
  • Prior malignancy allowed provided patient meets the following criteria:

    • Underwent potentially curative therapy for all prior malignancies and is deemed at low risk for recurrence
    • No malignancy for the past 5 years (except effectively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix effectively treated with surgery alone, lobular carcinoma in situ of the ipsilateral or contralateral breast treated with surgery alone, or carcinoma of the mouth that is in situ or minimally invasive) and no evidence of recurrence
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • No prior radiotherapy to cervical lymph nodes


  • See Disease Characteristics
  • No prior surgery to cervical lymph nodes
  • No prior tumor resection involving the neck


  • No other nuclear medicine imaging study with fludeoxyglucose F 18 within the past 24 hours
  • No other nuclear medicine imaging study with technetium Tc 99 within the past 48 hours
  • No other nuclear medicine imaging study with iodine I 123 within the past 96 hours
  • No other nuclear medicine imaging study with T1-201 or gadolinium Ga 67 within the past 2 weeks
  • No other nuclear medicine imaging study with iodine I 131 within the past 2 months
  • No other prior therapy to cervical lymph nodes
18 Years and older
Contact information is only displayed when the study is recruiting subjects
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United States,   Canada
CDR0000069485, ACOSOG-Z0360
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American College of Surgeons
National Cancer Institute (NCI)
Study Chair: Francisco Civantos, MD University of Miami Sylvester Comprehensive Cancer Center
National Cancer Institute (NCI)
March 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP