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Oral Cavity Squamous Cell CarcinomaPhase 2NCT07121595

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

A Phase 2 study testing Biospecimen Collection, Carboplatin and Cisplatin in people with Oral Cavity Squamous Cell Carcinoma and Stage I Lip and Oral Cavity Cancer AJCC v8, run by University of Michigan Rogel Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Carboplatin and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
17 Jul 2025to 1 Jul 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Cancer AnswerLine contact

1-800-865-1125

CancerAnswerLine@med.umich.edu

United States1 site, 1 recruiting

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

    Cancer AnswerLine, 800-865-1125, CancerAnswerLine@med.umich.edu

    Jennifer L. Shah

    Recruiting

Other trials in United States

About this study

Official title: PRECEDENT: Pilot Phase II Study of Personalized Radiation to the Contralateral Neck Directed by Sentinel Node Evaluation in Lateralized Oral Cavity Squamous Cell Carcinoma

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.

Being tested
Biospecimen Collection, Carboplatin, Cisplatin, Computed Tomography, Modified Barium Swallow
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Mouth Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • CarboplatinDrug

    Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino

    Given IV

  • CisplatinDrug

    Also called Abiplatin, Blastolem, Briplatin, CDDP

    Given IV

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT and/or SPECT-CT

  • Modified Barium SwallowProcedure or surgery

    Also called MBS, VFSS, Videofluoroscopic Swallowing Study

    Undergo video fluoroscopic swallow study

  • PaclitaxelDrug

    Also called Anzatax, Asotax, Bristaxol, Praxel

    Given IV

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET-CT

  • Questionnaire AdministrationOther

    Ancillary studies

  • Radiation TherapyRadiation

    Also called Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate

    Undergo RT

  • Sentinel Lymph Node BiopsyProcedure or surgery

    Also called Sentinel Node Biopsy, Sentinel node biopsy alone, SLNB, SNB

    Undergo SLNB

  • Single Photon Emission Computed TomographyProcedure or surgery

    Also called Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, Single-Photon Emission Computed, single-photon emission computed tomography

    Undergo SPECT-CT

  • Technetium Tc 99m-labeled TilmanoceptRadiation

    Also called 99mTc-Diethylenetriamine Pentaacetic Acid-Mannosyl-Dextran, 99mTc-DTPA-Mannosyl-Dextran, Lymphoseek, Tc99m Tilmanocept

    Given via injection

  • Technetium Tc-99m Sulfur ColloidOther

    Also called Tc 99m Sulfur Colloid, Tc-99m SC, Technetium Tc 99m Sulfur Colloid

    Given via injection

Study groups in NCT07121595
Study groupRoleWhat they receive
Treatment (SLN mapping, SLNB, RT, chemotherapy)ExperimentalSee Detailed Description.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. Change in neck function

    Will be assessed using five number summary* (minimum [min], first quartile [Q1], median, third quartile [Q3], maximum [max]) of Neck Dissection Impairment Index summary scores.

    Measured: Baseline up to 1 year from completion of definitive treatment

  2. Change in oral and oropharyngeal dryness

    Will be assessed using five number summary* (min, Q1, median, Q3, max) of summary score on the Xerostomia questionnaire.

    Measured: Baseline up to 3 months from completion of definitive treatment

  3. Change in quality of life

    Will be assessed using five number summary* (min, Q1, median, Q3, max) of summary score on the University of Washington Quality of Life Survey, a 15-item survey evaluating quality of life metrics focused on speech, eating, saliva, taste, phlegm, employment, recreation, activity, disfigurement, and pain.

    Measured: Baseline up to 3 months from completion of definitive treatment

  4. Recurrence free survival

    Will assess # evaluable, # events and # censored at 1 year from completion of definitive treatment, as well as Kaplan-Meier (KM) estimate with 95% CI.

    Measured: 1 year from completion of definitive treatment

  5. Overall survival

    Will assess # evaluable, # events and # censored at 1 year from completion of definitive treatment, as well as KM estimate with 95% CI.

    Measured: 1 year from completion of definitive treatment

  6. Disease-specific survival

    Will assess # evaluable, # events and # censored at 1 year from completion of definitive treatment, as well as KM estimate with 95% CI.

    Measured: 1 year from completion of definitive treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2025
  2. Study start17 Jul 2025
  3. Primary completion1 Jul 2030 (estimated)
  4. Study completion1 Jul 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07121595
Sponsor's protocol ID
UMCC 2023.022
Other IDs
NCI-2025-01191, HUM00258370
Status last verified
Jul 2026
First submitted
6 Aug 2025
Last updated
31 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biospecimen Collection, Carboplatin and Cisplatin in people with Oral Cavity Squamous Cell Carcinoma and Stage I Lip and Oral Cavity Cancer AJCC v8, run by University of Michigan Rogel Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cancer AnswerLine (1-800-865-1125, CancerAnswerLine@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Contralateral regional control rate (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07121595.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.

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