Personalized Neck Radiation Therapy Directed by Sentinel Lymph Node Biopsy for the Treatment of Oral Cavity Squamous Cell Carcinoma, PRECEDENT Trial
NCT ID: NCT07121595
Last Updated: 2025-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
50 participants
INTERVENTIONAL
2025-07-17
2030-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (SLN mapping, SLNB, RT, chemotherapy)
See Detailed Description.
Biospecimen Collection
Undergo blood sample collection
Carboplatin
Given IV
Cisplatin
Given IV
Computed Tomography
Undergo CT and/or SPECT-CT
Modified Barium Swallow
Undergo video fluoroscopic swallow study
Paclitaxel
Given IV
Positron Emission Tomography
Undergo PET-CT
Questionnaire Administration
Ancillary studies
Radiation Therapy
Undergo RT
Sentinel Lymph Node Biopsy
Undergo SLNB
Single Photon Emission Computed Tomography
Undergo SPECT-CT
Technetium Tc 99m-labeled Tilmanocept
Given via injection
Technetium Tc-99m Sulfur Colloid
Given via injection
Interventions
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Biospecimen Collection
Undergo blood sample collection
Carboplatin
Given IV
Cisplatin
Given IV
Computed Tomography
Undergo CT and/or SPECT-CT
Modified Barium Swallow
Undergo video fluoroscopic swallow study
Paclitaxel
Given IV
Positron Emission Tomography
Undergo PET-CT
Questionnaire Administration
Ancillary studies
Radiation Therapy
Undergo RT
Sentinel Lymph Node Biopsy
Undergo SLNB
Single Photon Emission Computed Tomography
Undergo SPECT-CT
Technetium Tc 99m-labeled Tilmanocept
Given via injection
Technetium Tc-99m Sulfur Colloid
Given via injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical stage cT1-4a N0-2b M0 within 42 days of study enrollment based on the following work-up:
* History and physical examination within 42 days of study enrollment; must include documentation of lateralized primary tumor site
* Cross-sectional imaging of the head and neck within 42 days of study enrollment
* Cross-sectional imaging of the chest within 42 days of study enrollment
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 within 42 days of study enrollment
* Age \> 18
* Recommended treatment plan is surgical resection with ipsilateral neck dissection and SPECT-CT-guided sentinel node biopsy. Flap reconstruction is allowed
* Patient is willing and able to provide informed consent. Patient provides study-specific informed consent prior to study entry
* Women of childbearing potential and male participants must agree to use medically effect means of birth control throughout their participation in the treatment phase of the study
Exclusion Criteria
* Evidence of contralateral neck disease on staging imaging
* Prior non-head and neck invasive malignancy (except non-melanomatous skin cancer, including effectively treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or cervix) unless disease free for ≥ 2 years
* Diagnosis of head and neck squamous cell carcinoma (SCC) in the oropharynx, nasopharynx, hypopharynx, and larynx
* Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowed. Prior immunotherapy for the study cancer is allowed.
* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
* Patient with severe, active co-morbidity that would preclude an elective or completion neck dissection
* Pregnant and breast-feeding patients
* Excisional biopsy for study cancer
* Prior surgery involving the lateral neck, including neck dissection or gross injury to the neck that would preclude surgical dissection for this trial. Prior thyroid and central neck surgery is permissible; incisional biopsy is permitted
* Underlying or documented history of hematologic malignancy (e.g., chronic lymphocytic leukemia \[CLL\]) or other active disease capable of causing lymphadenopathy (sarcoidosis or untreated mycobacterial infection)
* Actively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte or immunomodulatory therapy
* Currently participating in another investigational therapeutic trial
18 Years
ALL
No
Sponsors
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University of Michigan Rogel Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Jennifer L Shah
Role: PRINCIPAL_INVESTIGATOR
University of Michigan Rogel Cancer Center
Locations
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University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2025-01191
Identifier Type: REGISTRY
Identifier Source: secondary_id
HUM00258370
Identifier Type: OTHER
Identifier Source: secondary_id
UMCC 2023.022
Identifier Type: -
Identifier Source: org_study_id
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