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Home > "D" Clinical Trials Conditions > Diagnostic Trial in Patients Who Are Undergoing Surgery for Early Stage Mouth Cancer  Diagnostic Trial in Patients Who Are Undergoing Surgery for Early Stage Mouth Cancer
Diagnostic Trial in Patients Who Are Undergoing Surgery for Early Stage Mouth Cancer
For Condition: stage 2 squamous cell carcinoma of the lip and oral cavity,stage 1 squamous cell carcinoma of the lip and oral cavity
Status: Recruiting
Sponsor(s): American College of Surgeons , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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. 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - 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 PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 OR - Zubrod 0-2 Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - 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 PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy to cervical lymph nodes Surgery - See Disease Characteristics - No prior surgery to cervical lymph nodes - No prior tumor resection involving the neck Other - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
FranciscoCivantos, Study Chair, Sylvester Cancer Center
Cancer Institute at Oregon Health and Science University *Recruiting*
Portland, Oregon, 97239-3098
United States
Recruiting Brett Sheppard 503-494-8372
American Fork Hospital *Recruiting*
American Fork, Utah, 84003
United States
Recruiting R. Noyes 801-408-3555
West Virginia University Hospitals *Recruiting*
Morgantown, West Virginia, 26506-9300
United States
Recruiting Geoffrey Graeber 304-293-4180
Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus, Ohio, 43210-1240
United States
Recruiting David Schuller 614-293-4878
LDS Hospital *Recruiting*
Salt Lake City, Utah, 84143
United States
Recruiting R. Noyes 801-408-3555
University of Iowa Hospitals and Clinics *Recruiting*
Iowa City, Iowa, 52242-1083
United States
Recruiting Russell Smith 319-356-4351
Hollings Cancer Center at Medical University of South Carolina *Recruiting*
Charleston, South Carolina, 29425
United States
Recruiting Carolyn Reed 843-792-3362
Siteman Cancer Center *Recruiting*
St. Louis, Missouri, 63110-1093
United States
Recruiting Timothy Eberlein 314-454-1898
Medical College of Georgia Comprehensive Cancer Center *Recruiting*
Augusta, Georgia, 30912-4000
United States
Recruiting Mark Anstadt 706-721-3226
Evanston Northwestern Health Care - Evanston Hospital *Recruiting*
Evanston, Illinois, 60201
United States
Recruiting David Winchester 847-570-2807
Watson Clinic *Recruiting*
Lakeland, Florida, 33804-5000
United States
Recruiting Pranay Patel 863-680-7631
University of Mississippi Medical Center *Recruiting*
Jackson, Mississippi, 39216-4505
United States
Recruiting William Barber 601-984-5080
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Jeffrey Myers 713-745-2667
McLaren Regional Cancer Center *Recruiting*
Flint, Michigan, 48432
United States
Recruiting Sukamal Saha 810-230-9600
Cardinal Bernardin Cancer Center at Loyola University Medical Center *Recruiting*
Maywood, Illinois, 60153
United States
Recruiting Guy Petruzelli 708-216-8526
Ellis Fischel Cancer Center at University of Missouri - Columbia *Recruiting*
Columbia, Missouri, 65203
United States
Recruiting Robert Zitsch 573-882-8173
Fox Chase Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111-2497
United States
Recruiting Elin Sigurdson 215-728-3519
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Jatin Shah 212-639-7233
Baylor University Medical Center *Recruiting*
Dallas, Texas, 75246
United States
Recruiting Joseph Kuhn 214-824-9963
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294-3300
United States
Recruiting Marshall Urist 205-934-3028
H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa, Florida, 33612-9497
United States
Recruiting Thomas McCaffrey 813-972-8463
CancerCare Manitoba *Recruiting*
Winnipeg, Manitoba, R3E 0V9
Canada
Recruiting Richard Nason 204-787-1094
University of Miami Sylvester Cancer Center *Recruiting*
Miami, Florida, 33136
United States
Recruiting Francisco Civantos 305-243-5276
Penn State Cancer Institute at Milton S. Hershey Medical Center *Recruiting*
Hershey, Pennsylvania, 17033-0850
United States
Recruiting Brendan Stack 717-531-8945
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville, Tennessee, 37232-6838
United States
Recruiting Stephen Bayles 615-343-8840
Additional Information:
Study ID Numbers: CDR0000069485; ACOSOG-Z0360
Study Start Date:
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00042926
Other Stage 1 Squamous Cell Carcinoma Of The Lip And Oral Cavity Studies:
1. Diagnostic Trial in Patients Who Are Undergoing Surgery for Early Stage Mouth Cancer
2. Erlotinib and Radiation Therapy With or Without Cisplatin in Treating Patients With Mouth or Throat Cancer
3. Surgery and Radiation Therapy With or Without Interleukin-2 in Treating Patients With Cancer of the Mouth or Oropharynx
Related Studies:
Other stage 1 squamous cell carcinoma of the lip and oral cavity Clinical Trials
Other Missouri Clinical Trials
Other St. Louis Clinical Trials
Diagnostic Trial in Patients Who Are Undergoing Surgery for Early Stage Mouth Cancer
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