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Phase II Study for Head and Neck Cancer Radiation Treatment

This study is a Phase II clinical trial for people with head and neck cancer. It compares two ways of giving radiation therapy: Elective Nodal Irradiation (ENI) and Involved Nodal Radiotherapy (INRT). Both methods use Intensity Modulated Radiation Therapy (IMRT) and may include chemotherapy with cisplatin, cetuximab, or carboplatin-paclitaxel. INRT is an experimental treatment that targets potentially cancerous lymph nodes more specifically, aiming to reduce side effects by limiting radiation to healthy tissue. The study wants to see if INRT is as effective as ENI in preventing the cancer from returning in the treated area after two years. You can join if you are 18 to 99 years old and have a specific type of head and neck cancer (squamous cell carcinoma of the oropharynx, larynx, or hypopharynx) with measurable disease. The current recruitment status is unclear.

Study design
This is a single-blinded, randomized Phase II study comparing two radiation treatments, with a planned enrollment of 80 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at two years, indicating participants will be followed for at least that long.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06477692

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

Recruiting
PHASE2Ages 18–99InterventionalTreatment
University of Texas Southwestern Medical Center
~80 participants
Updated 2026-04-17 on ClinicalTrials.gov
What's tested:ENI using IMRT with or without chemotherapyINRTENI

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The probability at two years: SEVR in INRT versus ENI patients
Measured over 2 years

Conditions

Head and Neck Cancer

Explore related trials

Hypopharyngeal Squamous Cell CarcinomaLaryngeal Squamous Cell CarcinomaMalignant Head and Neck NeoplasmOropharyngeal Squamous Cell Carcinoma

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • David Sher, MD · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

Who to contact

Sarah Neufeld
[email protected]
214-645-8525
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • The probability at two years: SEVR in INRT versus ENI patients2 years

    The probability at two years will be compared between the arms using a one- sided Fisher's exact test (probability of SEVR between the arms).