Recruiting
Phase 2

Personalized Radiation

Sponsor:

University of Michigan Rogel Cancer Center

Code:

NCT07121595

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Carboplatin

Cisplatin

Computed Tomography

Modified Barium Swallow

Study Details

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

Study ID

NCT07121595

Start date

Jul 17, 2025

Status verified date

Jul, 2026

Completion date

Jul 1, 2030

Anticipated

Primary completion date

Jul 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (SLN mapping, SLNB, RT, chemotherapy)

See Detailed Description.

Interventions

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

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 ]

Central Contacts and Locations

Central contacts

Cancer AnswerLine

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

Locations

University of Michigan Comprehensive Cancer Center

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Cancer AnswerLine

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

Principal Investigator:

Jennifer L. Shah

More Information

Sponsor

University of Michigan Rogel Cancer Center

Last update posted

Jul 31, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan Rogel Cancer Center on 2026-07-31.