Personalized neck radiation guided by sentinel lymph node biopsy for oral cavity cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II interventional trial uses SPECT-CT-guided sentinel lymph node biopsy (SLNB) at the time of surgical resection and ipsilateral neck dissection to map nodal drainage from lateralized oral cavity tumors. SLNB results will be used to personalize adjuvant radiotherapy fields, potentially omitting contralateral neck irradiation when sentinel nodes do not indicate spread. Standard radiation planning, imaging (CT, chest imaging), and systemic agents such as cisplatin or carboplatin may be used per protocol when indicated. The main goal is to determine whether SLNB-directed radiation reduces treatment to the uninvolved side of the neck without increasing contralateral recurrence.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Michigan Comprehensive Cancer Center
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Principal investigator: Jennifer L Shah — University of Michigan Rogel Cancer Center
• Study coordinator: Cancer AnswerLine
• Email: CancerAnswerLine@med.umich.edu
• Phone: 1-800-865-1125

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Sentinel lymph node biopsy versus standard neck dissection for early-stage oral cavity cancer

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• Camonsertib added to precise radiation therapy for recurrent head and neck cancer

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• Combining Ipatasertib with Chemotherapy and Radiation for Head and Neck Cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.