Personalized Neck Radiation Therapy Directed by Sentinel Lymph Node Biopsy for the Treatment of Oral Cavity Squamous Cell Carcinoma, PRECEDENT Trial

NCT07121595 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: UMCC 2023.022NCI-2025-01191HUM00258370
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well personalized neck radiation therapy directed by sentinel lymph node biopsy (SLNB) works in treating patients with oral cavity squamous cell carcinoma (OCSCC). SLNB can be performed as part of standard care for OCSCC. During SLNB, a radiotracer is injected around the tumor. The lymph nodes are then biopsied and tested to see if the tracer injected into the tumor traveled to and is present in the sentinel lymph nodes (SLNs). Results of the SLNB are used to determine whether lymph nodes should be removed in both sides of the neck or just on the same side as the primary tumor. Standard treatment then involves radiation therapy to both sides of the neck, regardless of SLNB results. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Studies have shown only a small number of patients develop a return of the cancer (recurrence) in the opposite side of the neck after radiation therapy. In addition, radiation therapy can negatively impact patient outcomes like saliva production, speech and swallow function, increased risk of radiation induced cancers, and chronic pain. Standard of care SLNBs may be effective in determining whether radiation therapy only needs to be administered to one side of the neck or both sides. This may help spare tissue on the opposite side of the neck from receiving radiation if there is no indication of lymph node involvement there.

Conditions

Oral Cavity Squamous Cell Carcinoma; Stage I Lip and Oral Cavity Cancer AJCC v8; Stage II Lip and Oral Cavity Cancer AJCC v8; Stage III Lip and Oral Cavity Cancer AJCC v8; Stage IVA Lip and Oral Cavity Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• Contralateral regional control rate

  Contralateral regional control rate is defined as the proportion of evaluable subjects free of contralateral neck recurrence at 1 year from completion of definitive treatment. Regional Recurrence is defined as biopsy-proven cancer within the ipsilateral or contralateral neck at any time point after initial surgical resection. When biopsy is not feasible, evidence of recurrence by imaging suffices only with documented attestation at tumor board that the imaging is clinically diagnostic of regional recurrence. Cumulative incidence function estimate with 90% confidence interval (CI) for follow-up after 1 year.

  From completion of definitive treatment to neck recurrence date, death date or date of last contact, assessed at 1 year from completion of definitive treatment

Secondary Outcomes (6)

• Change in neck function

  Baseline up to 1 year from completion of definitive treatment

• Change in oral and oropharyngeal dryness

  Baseline up to 3 months from completion of definitive treatment

• Change in quality of life

  Baseline up to 3 months from completion of definitive treatment

• Recurrence free survival

  1 year from completion of definitive treatment

• Overall survival

  1 year from completion of definitive treatment

Study Arms (1)

Treatment (SLN mapping, SLNB, RT, chemotherapy)

EXPERIMENTAL

See Detailed Description.

Procedure: Biospecimen Collection; Drug: Carboplatin; Drug: Cisplatin; Procedure: Computed Tomography; Procedure: Modified Barium Swallow; Drug: Paclitaxel; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Radiation: Radiation Therapy; Procedure: Sentinel Lymph Node Biopsy; Procedure: Single Photon Emission Computed Tomography; Radiation: Technetium Tc 99m-labeled Tilmanocept; Other: Technetium Tc-99m Sulfur Colloid

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (SLN mapping, SLNB, RT, chemotherapy)

Carboplatin DRUG

Given IV

Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, JM8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo

Treatment (SLN mapping, SLNB, RT, chemotherapy)

Cisplatin DRUG

Given IV

Also known as: Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin

Treatment (SLN mapping, SLNB, RT, chemotherapy)

Computed Tomography PROCEDURE

Undergo CT and/or SPECT-CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography

Treatment (SLN mapping, SLNB, RT, chemotherapy)

Modified Barium Swallow PROCEDURE

Undergo video fluoroscopic swallow study

Also known as: MBS, VFSS, Videofluoroscopic Swallowing Study

Treatment (SLN mapping, SLNB, RT, chemotherapy)

Paclitaxel DRUG

Given IV

Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat

Treatment (SLN mapping, SLNB, RT, chemotherapy)

Positron Emission Tomography PROCEDURE

Undergo PET-CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

Treatment (SLN mapping, SLNB, RT, chemotherapy)

Questionnaire Administration OTHER

Ancillary studies

Treatment (SLN mapping, SLNB, RT, chemotherapy)

Radiation Therapy RADIATION

Undergo RT

Also known as: Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation

Treatment (SLN mapping, SLNB, RT, chemotherapy)

Sentinel Lymph Node Biopsy PROCEDURE

Undergo SLNB

Also known as: Sentinel Node Biopsy, Sentinel node biopsy alone, SLNB, SNB

Treatment (SLN mapping, SLNB, RT, chemotherapy)

Single Photon Emission Computed Tomography PROCEDURE

Undergo SPECT-CT

Also known as: Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, Single-Photon Emission Computed, single-photon emission computed tomography, SPECT, SPECT imaging, SPECT SCAN, SPET, ST, tomography, emission computed, single photon, Tomography, Emission-Computed, Single-Photon

Treatment (SLN mapping, SLNB, RT, chemotherapy)

Technetium Tc 99m-labeled Tilmanocept RADIATION

Given via injection

Also known as: 99mTc-Diethylenetriamine Pentaacetic Acid-Mannosyl-Dextran, 99mTc-DTPA-Mannosyl-Dextran, Lymphoseek, Tc99m Tilmanocept, TECHNETIUM TC-99M TILMANOCEPT

Treatment (SLN mapping, SLNB, RT, chemotherapy)

Technetium Tc-99m Sulfur Colloid OTHER

Given via injection

Also known as: Tc 99m Sulfur Colloid, Tc-99m SC, Technetium Tc 99m Sulfur Colloid

Treatment (SLN mapping, SLNB, RT, chemotherapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must have biopsy-proven squamous cell carcinoma of the oral cavity
• 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

You may not qualify if:

• Evidence of distant metastatic disease based on clinical or radiologic evaluation
• 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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Mouth Neoplasms

Interventions

Specimen Handling; Carboplatin; Cisplatin; 1,2-diaminocyclohexaneplatinum II citrate; Platinum; Paclitaxel; Taxes; Magnetic Resonance Spectroscopy; Radiotherapy; Radiation; Sentinel Lymph Node Biopsy; X-Rays; Photons; technetium-diethylenetriaminepentaacetic acid-mannosyl-dextran; Technetium Tc 99m Sulfur Colloid

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Metals, Heavy; Elements; Transition Elements; Metals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations; Spectrum Analysis; Chemistry Techniques, Analytical; Therapeutics; Physical Phenomena; Biopsy; Cytodiagnosis; Cytological Techniques; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Radiation, Ionizing; Elementary Particles; Light; Optical Phenomena; Radiation, Nonionizing; Sulfur Compounds; Technetium Compounds

Study Officials

• Jennifer L Shah

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cancer AnswerLine

CONTACT

1-800-865-1125; CancerAnswerLine@med.umich.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 13, 2025
• Study Start: July 17, 2025
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: August 13, 2025

Record last verified: 2025-08

Locations

US (1)