Personalized Neck Radiation Therapy Guided by Sentinel Lymph Node Biopsy for Treating Oral Cavity Squamous Cell Carcinoma
Sponsor: University of Michigan Rogel Cancer Center
ClinicalTrials ID:NCT07121595
This study is exploring a new approach to radiation therapy for patients with oral cavity squamous cell carcinoma. By using sentinel lymph node biopsy, doctors aim to personalize treatment and potentially reduce the amount of radiation needed, which may help preserve important functions like speech and swallowing.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This clinical trial is investigating how well a personalized approach to neck radiation therapy works for patients with oral cavity squamous cell carcinoma (OCSCC). The study uses a technique called sentinel lymph node biopsy (SLNB) to help decide if radiation should be given to one or both sides of the neck. During SLNB, a special tracer is injected near the tumor to see if it reaches the sentinel lymph nodes. This helps determine if cancer has spread to the lymph nodes. Normally, radiation is given to both sides of the neck, but this study aims to see if treating only the affected side can be just as effective, potentially reducing side effects like dry mouth, speech and swallowing difficulties, and other long-term issues.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of squamous cell carcinoma in the oral cavity.
- Cancer must be at a specific stage (cT1-4a N0-2b M0) within 42 days before joining the study, based on:
- A medical history and physical exam, including details about the tumor location.
- Imaging scans of the head, neck, and chest.
- Must have an ECOG performance status of 0 to 2 within 42 days before joining the study.
- Must be over 18 years old.
- The treatment plan should include surgery with neck dissection and sentinel node biopsy guided by SPECT-CT. Flap reconstruction is allowed.
- Must be willing and able to give informed consent.
- Women who can become pregnant and male participants must agree to use effective birth control during the study.
Exclusion Criteria
- Evidence of cancer spread to distant parts of the body.
- Cancer found in the opposite side of the neck on imaging.
- History of other invasive cancers unless disease-free for at least 2 years, except for certain skin cancers or carcinoma in situ of the breast or cervix.
- Diagnosis of squamous cell carcinoma in other head and neck areas like the oropharynx, nasopharynx, hypopharynx, or larynx.
- Previous chemotherapy for the study cancer, although chemotherapy for other cancers is allowed. Previous immunotherapy for the study cancer is allowed.
- Previous radiation in the area that would overlap with the study treatment.
- Severe health conditions that would prevent neck surgery.
- Pregnant or breastfeeding.
- Previous excisional biopsy for the study cancer.
- Previous surgery on the side of the neck involved in the study, except for thyroid or central neck surgery.
- History of blood cancers or other diseases causing swollen lymph nodes.
- Currently receiving certain cancer treatments or participating in another clinical trial.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Michigan Comprehensive Cancer Center | 48109 | Ann Arbor | Michigan |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.