Comparing two types of radiation therapy for head and neck cancer

INVERT - Prospective Phase II Randomized Trial of Involved Nodal Versus Elective Neck RadioTherapy

This study is testing whether a new type of radiation therapy that focuses on specific cancerous areas can help people with head and neck cancer while causing fewer side effects than the standard treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: University of Texas Southwestern Medical Center (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Dallas, Texas)
• Trial ID: NCT06477692 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of involved nodal radiotherapy (INRT) compared to elective nodal irradiation (ENI) in patients with head and neck cancer. Participants will be randomly assigned to receive either the standard ENI treatment or the experimental INRT, which targets potentially cancerous nodes identified by an AI program. The goal is to reduce radiation exposure to healthy tissues, thereby minimizing side effects. Patients will be blinded to their treatment assignment during the trial.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with pathologically-proven squamous cell carcinoma of the oropharynx, larynx, or hypopharynx.

Not a fit: Patients with squamous cell carcinoma of unknown primary or those with early-stage glottic cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective and less harmful radiation treatment options for patients with head and neck cancer.

How similar studies have performed: Other studies have shown promise in using targeted radiation approaches, but this specific methodology utilizing AI for node identification is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Pathologically-proven diagnosis of squamous cell carcinoma of the oropharynx, larynx, or hypopharynx. Squamous cell carcinoma of unknown primary is not allowed.
* Patients must have clinically or radiographically evident measureable disease at the primary site and/or nodal stations. Diagnostic lymph node excision (≤ 2 nodes) is also allowable.
* Patients may undergo a diagnostic or therapeutic transoral resection for a T1-2 tonsil or base of tongue cancer.
* Clinical stage I-IVB (AJCC, 7th edition); stages I-II glottic cancer are excluded
* Age ≥ 18 years.
* ECOG Performance Status 0-2
* All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study treatment, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
* A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria Has not undergone a hysterectomy or bilateral oophorectomy; or Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
* Neck CT and/or neck MRI, and PET-CT
* Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Distant metastasis.
* Inability to undergo either a diagnostic CT with contrast or simulation CT with contrast.
* Inability to undergo PET-CT.
* Stage I and II glottic carcinoma.
* Gross total excision of both the primary and nodal disease.
* Synchronous non-skin cancer primaries outside of the oropharynx, larynx, and hypopharynx except for low- and intermediate-risk prostate cancer and synchronous well-differentiated thyroid cancer; in the latter case, surgery may occur before or after treatment, provided all other eligibility criteria are met.
* Prior invasive malignancy with an expected disease-free interval of less than 3 years.
* Prior systemic chemotherapy for the study cancer; prior chemotherapy for a remote cancer is allowable.
* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields.
* Subjects may not be receiving any other investigational agents.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the chemotherapy agents in this study (if necessary).
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
* History of severe immunosuppression, including HIV, and organ or autologous or allogeneic stem cell transplant.

Where this trial is running

Dallas, Texas

• UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)

Study contacts

• Principal investigator: David Sher, MD — University of Texas Southwestern Medical Center
• Study coordinator: Sarah Neufeld

Conditions Head and Neck Cancer