Personalized neck radiation guided by sentinel lymph node biopsy for oral cavity cancer
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 sees if using sentinel lymph node biopsy to guide which side(s) of the neck get radiation can safely reduce unnecessary radiation for people with oral cavity squamous cell carcinoma.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Rogel Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT07121595 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (over 18) with biopsy-proven, lateralized oral cavity squamous cell carcinoma staged cT1-4a N0-2b M0 who are planned for surgical resection with ipsilateral neck dissection and SPECT-CT-guided sentinel lymph node biopsy and have ECOG 0-2 are ideal candidates.
Not a fit: Patients with midline or bilateral primary tumors, known bilateral nodal disease requiring bilateral treatment, inability to undergo SLNB, or poor performance status are unlikely to benefit from this personalized radiation approach.
Why it matters
Potential benefit: If successful, this approach could spare many patients from unnecessary contralateral neck radiation and reduce treatment-related toxicity and long-term side effects.
How similar studies have performed: Sentinel lymph node biopsy is an established staging technique with low reported rates of contralateral recurrence, but using SLNB results to omit contralateral radiation is a relatively novel approach with limited prospective evidence to date.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ann Arbor, Michigan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.