Diagnostic Trial in Patients Who Are Undergoing Surgery for Early Stage Mouth Cancer
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ClinicalTrials.gov Identifier: NCT00042926 |
Recruitment Status
:
Completed
First Posted
: January 27, 2003
Last Update Posted
: December 7, 2016
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Tracking Information | ||||
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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 |
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. |
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Detailed Description | OBJECTIVES:
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Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE | Head and Neck Cancer | |||
Intervention ICMJE |
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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:
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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. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
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 ) |
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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 |
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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 |