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
2 other identifiers
interventional
161
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable head-and-neck-cancer
Started May 2002
Longer than P75 for not_applicable head-and-neck-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2002
CompletedFirst Submitted
Initial submission to the registry
August 5, 2002
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedDecember 7, 2016
December 1, 2016
5 years
August 5, 2002
December 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of non-SLN(s) negative patients
Up to 30 days
Study Arms (1)
Radiolymphoscintigraphy + surgery
EXPERIMENTALPatients 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
Eligibility Criteria
You may qualify if:
- 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),
- +1 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 20142602RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Francisco Civantos, MD
University of Miami Sylvester Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2002
First Posted
January 27, 2003
Study Start
May 1, 2002
Primary Completion
May 1, 2007
Study Completion
November 1, 2010
Last Updated
December 7, 2016
Record last verified: 2016-12