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

ConditionsOral Cavity Squamous Cell CarcinomaStage I Lip and Oral Cavity Cancer AJCC v8Stage II Lip and Oral Cavity Cancer AJCC v8Stage III Lip and Oral Cavity Cancer AJCC v8Stage IVA Lip and Oral Cavity Cancer AJCC v8
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan Rogel Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Carboplatin

    Drug

    Given IV

  • Cisplatin

    Drug

    Given IV

  • Computed Tomography

    Procedure/Surgery

    Undergo CT and/or SPECT-CT

  • Modified Barium Swallow

    Procedure/Surgery

    Undergo video fluoroscopic swallow study

  • Paclitaxel

    Drug

    Given IV

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET-CT

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Radiation Therapy

    Radiation

    Undergo RT

  • Sentinel Lymph Node Biopsy

    Procedure/Surgery

    Undergo SLNB

  • Single Photon Emission Computed Tomography

    Procedure/Surgery

    Undergo SPECT-CT

  • Technetium Tc 99m-labeled Tilmanocept

    Radiation

    Given via injection

  • Technetium Tc-99m Sulfur Colloid

    Other intervention

    Given via injection

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Treatment (SLN mapping, SLNB, RT, chemotherapy)Experimental treatment 13 interventions

Trial outcomes

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.

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

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
1 year from completion of definitive treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan Rogel Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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