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

Tracking Information
First Submitted Date ICMJE	August 5, 2002
First Posted Date ICMJE	January 27, 2003
Last Update Posted Date	December 7, 2016
Study Start Date ICMJE	May 2002
Actual Primary Completion Date	May 2007 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: July 6, 2015)	Proportion of non-SLN(s) negative patients [ Time Frame: Up to 30 days ]
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00042926 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Diagnostic Trial in Patients Who Are Undergoing Surgery for Early Stage Mouth Cancer
Official Title ICMJE	A Trial Of Lymphatic Mapping And Sentinel Node Lymphadenectomy For Patients With T1 or T2 Clinically N0 Oral Cavity Squamous Cell Carcinoma
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 Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
Condition ICMJE	Head and Neck Cancer
Intervention ICMJE	Other: immunohistochemistry staining method; Procedure: conventional surgery; Procedure: lymphangiography; Procedure: radionuclide imaging; Procedure: sentinel lymph node biopsy; Radiation: technetium Tc 99m sulfur colloid
Study Arms	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.; Interventions: Other: immunohistochemistry staining method; Procedure: conventional surgery; Procedure: lymphangiography; Procedure: radionuclide imaging; Procedure: sentinel lymph node biopsy; Radiation: technetium Tc 99m sulfur colloid
Publications *	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.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: July 6, 2015)	161
Original Enrollment ICMJE	Not Provided
Actual Study Completion Date	November 2010
Actual Primary Completion Date	May 2007 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Not Provided
Removed Location Countries	Canada, United States
Administrative Information
NCT Number ICMJE	NCT00042926
Other Study ID Numbers ICMJE	ACOSOG-Z0360; CDR0000069485 ( Registry Identifier: NCI Physician Data Query )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Alliance for Clinical Trials in Oncology
Study Sponsor ICMJE	Alliance for Clinical Trials in Oncology
Collaborators ICMJE	National Cancer Institute (NCI)
Investigators ICMJE	Study Chair: Francisco Civantos, MD University of Miami Sylvester Comprehensive Cancer Center
PRS Account	Alliance for Clinical Trials in Oncology
Verification Date	December 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP