50 Participants Needed

Personalized Radiation Therapy for Oral Cancer

CA
Overseen ByCancer AnswerLine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method of using radiation therapy to treat oral cavity squamous cell carcinoma, a type of mouth cancer. Through a procedure called sentinel lymph node biopsy, doctors can determine if cancer has spread to lymph nodes, guiding the decision on whether radiation is needed on one or both sides of the neck. The goal is to minimize unnecessary radiation exposure, which can cause side effects like dry mouth or difficulty swallowing. This trial suits those diagnosed with this type of mouth cancer who might undergo surgery as part of their treatment. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are actively receiving systemic chemotherapy, immunosuppressive, or immunomodulatory therapy, you may not be eligible to participate.

What prior data suggests that this personalized neck radiation therapy and sentinel lymph node biopsy are safe for treating oral cancer?

Research has shown that sentinel lymph node biopsy (SLNB) is a safe and effective method for assessing early oral cavity cancers. Studies have found that SLNB generally does not cause major issues for patients. It primarily checks if cancer has spread to nearby lymph nodes, aiding doctors in deciding the best treatment plan.

For personalized neck radiation therapy, research indicates that only a few patients experience cancer returning on the untreated side of the neck. However, radiation therapy can sometimes lead to side effects, such as dry mouth, difficulty with speech or swallowing, and, in rare cases, other cancers caused by the radiation.

Overall, both SLNB and radiation therapy have been safely used in previous studies, but like any treatment, they can have side effects. It's important to consider these factors and discuss them with a doctor when considering participation in a clinical trial.12345

Why are researchers excited about this trial?

Researchers are excited about this trial for personalized radiation therapy in oral cancer because it aims to precisely target cancer cells while sparing healthy tissue. The treatment utilizes Sentinel Lymph Node Biopsy (SLNB), which helps identify the first lymph node where cancer is likely to spread, allowing for more accurate and less invasive treatment. This approach is different from standard treatments that often involve more extensive surgery and radiation, potentially reducing side effects and recovery time for patients. By focusing on personalized treatment plans, this method could enhance the effectiveness of radiation therapy and improve outcomes for oral cancer patients.

What evidence suggests that personalized neck radiation therapy directed by sentinel lymph node biopsy is effective for oral cancer?

Research shows that sentinel lymph node biopsy (SLNB), a treatment in this trial, effectively treats early-stage oral squamous cell carcinoma (OSCC). Studies indicate a 21.9% positivity rate, meaning it reliably detects cancer spread to the lymph nodes. SLNB also reduces shoulder and neck movement problems compared to other methods. Personalized neck radiation therapy, another treatment option in this trial, combined with chemotherapy, has improved the time patients live without cancer progression and overall survival rates. The aim is to target radiation more precisely, using SLNB data to potentially reduce unnecessary exposure. This approach could limit side effects like dry mouth and swallowing difficulties while still effectively treating cancer.56789

Who Is on the Research Team?

JL

Jennifer L Shah

Principal Investigator

University of Michigan Rogel Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with oral cavity squamous cell carcinoma who have not yet undergone treatment. It's designed to see if personalized neck radiation therapy based on sentinel lymph node biopsy results can be effective and reduce side effects.

Inclusion Criteria

My cancer is in stages 1 to 4a, may have spread to nearby lymph nodes but not to distant parts of the body.
I've had a physical exam within the last 42 days that noted where my tumor is located.
I've had a head and neck scan within the last 42 days.
See 7 more

Exclusion Criteria

I have had surgery on my neck but not in areas that would stop me from having surgery required by this trial.
Evidence of contralateral neck disease on staging imaging
I have been cancer-free for over 2 years, except for certain skin cancers or early-stage breast or cervical cancer.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sentinel Lymph Node Biopsy (SLNB)

Radiotracer is injected around the tumor, and lymph nodes are biopsied to determine the presence of the tracer in sentinel lymph nodes.

1 week
1 visit (in-person)

Radiation Therapy

Personalized neck radiation therapy is administered based on SLNB results to treat oral cavity squamous cell carcinoma.

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of neck function and quality of life.

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Personalized Neck Radiation Therapy
  • Sentinel Lymph Node Biopsy
Trial Overview The PRECEDENT trial tests whether using sentinel lymph node biopsy to guide radiation therapy can limit the treatment area, potentially sparing patients from unnecessary exposure and reducing complications like impaired saliva production and chronic pain.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (SLN mapping, SLNB, RT, chemotherapy)Experimental Treatment13 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials
303
Recruited
20,700+

Citations

Advances in radiotherapy for mouth neoplasmsIntensity-modulated radiotherapy, for example, has demonstrated 5-year overall survival rates ranging from 60 to 75%, with better local control ...
Post-operative radiotherapy for oral cavity squamous cell ...Salvage radiotherapy in patients with early loco-regional recurrence, but no distant metastases, results in a 3 year recurrence-free rate of 36 % (95 % CI: 23– ...
Outcomes among oropharyngeal and oral cavity cancer ...We also found that oral cavity cancers generally had poorer outcomes than oropharyngeal cancers, with 2-year LC rates of 85.1% vs 96.7% (p=0.031) ...
Outcomes of postoperative radiotherapy combined with or ...The findings indicated that the combination of radiotherapy and chemotherapy resulted in significantly greater progression-free survival (PFS, p = 0.04) and OS ...
Oncologic Significance of Therapeutic Delays in Oral ...Delays in initiating radiation therapy were associated with worse overall survival and disease-free survival. Meaning Efforts and resources ...
Outcomes among oropharyngeal and oral cavity cancer ...Our outcomes for postoperative VMAT for oral cavity and oropharyngeal cancers are encouraging, with high rates of loco-regional control. However ...
Personalized Neck Radiation Therapy Directed by Sentinel ...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 ...
Personalized Neck Radiation Therapy Directed by Sentinel ...In addition, radiation therapy can negatively impact patient outcomes like saliva production, speech and swallow function, increased risk of radiation induced ...
Personalized neck irradiation guided by sentinel lymph ...This is a multicenter randomized controlled trial aiming to compare safety and efficacy of treatment with SLNB guided neck irradiation versus standard bilateral ...
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