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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
immunohistochemistry staining method
conventional surgery
lymphangiography
radionuclide imaging
sentinel lymph node biopsy
technetium Tc 99m sulfur colloid
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Head and Neck Cancer focused on measuring stage I squamous cell carcinoma of the lip and oral cavity, stage II squamous cell carcinoma of the lip and oral cavity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Radiolymphoscintigraphy + surgery

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Proportion of non-SLN(s) negative patients

    Secondary Outcome Measures

    Full Information

    First Posted
    August 5, 2002
    Last Updated
    December 5, 2016
    Sponsor
    Alliance for Clinical Trials in Oncology
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00042926
    Brief Title
    Diagnostic Trial in Patients Who Are Undergoing Surgery for Early Stage Mouth Cancer
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2002 (undefined)
    Primary Completion Date
    May 2007 (Actual)
    Study Completion Date
    November 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Alliance for Clinical Trials in Oncology
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Head and Neck Cancer
    Keywords
    stage I squamous cell carcinoma of the lip and oral cavity, stage II squamous cell carcinoma of the lip and oral cavity

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    161 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Radiolymphoscintigraphy + surgery
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    immunohistochemistry staining method
    Intervention Type
    Procedure
    Intervention Name(s)
    conventional surgery
    Intervention Type
    Procedure
    Intervention Name(s)
    lymphangiography
    Intervention Type
    Procedure
    Intervention Name(s)
    radionuclide imaging
    Intervention Type
    Procedure
    Intervention Name(s)
    sentinel lymph node biopsy
    Intervention Type
    Radiation
    Intervention Name(s)
    technetium Tc 99m sulfur colloid
    Primary Outcome Measure Information:
    Title
    Proportion of non-SLN(s) negative patients
    Time Frame
    Up to 30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Francisco Civantos, MD
    Organizational Affiliation
    University of Miami Sylvester Comprehensive Cancer Center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20142602
    Citation
    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.
    Results Reference
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    Diagnostic Trial in Patients Who Are Undergoing Surgery for Early Stage Mouth Cancer

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