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1 Study Matches

Site for RANDOMIZED PHASE II/III TRIAL OF SENTINEL LYMPH NODE BIOPSY VERSUS ELECTIVE NECK DISSECTION FOR EARLY-STAGE ORAL CAVITY CANCER (NRG-HN006) (PSCI# 20-085)

The purpose of this study is to see if neck and shoulder function and pain are better after SLN biopsy surgery compared to the usual approach and to see if SLN biopsy surgery is as good as the usual approach in extending your time without cancer. SLN biopsy surgery is potentially less invasive compared to the usual approach, but it requires a radioactive imaging agent to see the lymph nodes and it could also cause side effects. These side effects are described in the risks section below. Your study doctor will choose the appropriate imaging agent, Lymphoseek or sulfur colloid, for use in your surgery. This study will help the study doctors find out if this different approach is better than the usual approach at improving neck and shoulder function. To decide if it is better, in the first part of the study, doctors will be looking to see if shoulder and neck function and quality of life are better after SLN biopsy surgery compared to the END surgery.
Tricia Morrison at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04333537
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Inclusion Criteria:
Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the oral cavity
Age ≥ 18
Zubrod Performance Status 0-2 within 42 days prior to registration
Only English speaking patients (able to read and understand English) are eligible to participate as the mandatory patient reported NDII tool is only available in this language
For women of child bearing potential, negative serum or urine pregnancy test within 42 days prior to registration
Exclusion Criteria:
Definitive clinical or radiologic evidence of regional (cervical) and/or distant metastatic disease
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
Patient with severe, active co-morbidity that would preclude an elective or completion neck dissection
Incomplete resection of oral cavity lesion with a positive margin; however, an excision biopsy is permitted
Actively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte or immunomodulatory therapy.
Cancer
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Location
Hershey, PA