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NCT06477692 | NOT YET RECRUITING | Head and Neck Cancer

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

University of Texas Southwestern Medical Center

Information provided by (Responsible Party):

David Sher

Brief Summary:

To determine the risk of solitary elective volume recurrence following involved nodal radiotherapy (INRT) versus elective nodal irradiation (ENI)

Condition or disease

Head and Neck Cancer

Intervention/treatment

ENI using IMRT with or without chemotherapy

INRT

ENI

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 80 participants
Masking : SINGLE
Masking Description : Patients are blinded to their treatment.
Primary Purpose : TREATMENT
Official Title : INVERT - Prospective Phase II Randomized Trial of Involved Nodal Versus Elective Neck RadioTherapy
Actual Study Start Date : 2024-12-01
Estimated Primary Completion Date : 2028-07-01
Estimated Study Completion Date : 2028-07-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 99 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Invert-Prospective Phase II Randomized Trial of Involved Nodal Versus Elective Neck RadioTherapy

Location Details

NCT06477692

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Locations

Not yet recruiting

United States, Texas

UT Southwestern Medical Center

dallas, Texas, United States, 75390