Actively Recruiting
Invert-Prospective Phase II Randomized Trial of Involved Nodal Versus Elective Neck RadioTherapy
Led by University of Texas Southwestern Medical Center · Updated on 2026-04-17
80
Participants Needed
1
Research Sites
189 weeks
Total Duration
On this page
Sponsors
U
University of Texas Southwestern Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
To determine the risk of solitary elective volume recurrence following involved nodal radiotherapy (INRT) versus elective nodal irradiation (ENI)
CONDITIONS
Official Title
Invert-Prospective Phase II Randomized Trial of Involved Nodal Versus Elective Neck RadioTherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically-proven diagnosis of squamous cell carcinoma of the oropharynx, larynx, or hypopharynx
- Clinically or radiographically measurable disease at primary site and/or nodal stations; diagnostic lymph node excision of 2 nodes or fewer allowed
- Diagnostic or therapeutic transoral resection allowed for T1-2 tonsil or base of tongue cancer
- Clinical stage I-IVB (AJCC 7th edition); excludes stages I-II glottic cancer
- Age 18 years or older
- ECOG Performance Status 0-2
- Men and women of child-bearing potential must use adequate contraception before, during, and for 90 days after treatment
- Female of child-bearing potential defined as woman not postmenopausal for at least 12 consecutive months or without hysterectomy/bilateral oophorectomy
- Neck CT and/or MRI and PET-CT required
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- Presence of distant metastasis
- Inability to undergo diagnostic or simulation CT with contrast
- Inability to undergo PET-CT
- Stage I and II glottic carcinoma
- Gross total excision of both primary and nodal disease
- Synchronous non-skin cancer outside oropharynx, larynx, hypopharynx except low/intermediate-risk prostate or well-differentiated thyroid cancer
- Prior invasive malignancy with expected disease-free interval less than 3 years
- Prior systemic chemotherapy for current cancer
- Prior radiotherapy overlapping study region
- Receiving other investigational agents
- History of allergic reactions to chemotherapy agents used in study
- Uncontrolled illness including active infection, symptomatic heart failure, unstable angina, arrhythmia, psychiatric illness or social situations limiting compliance
- Severe immunosuppression including HIV or prior organ/stem cell transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
S
Sarah Neufeld
CONTACT
L
Liliana Robles
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here