RECRUITING

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

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Conditions

Head and Neck Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-11-14
Study Completion:2028-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06477692

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pathologically-proven diagnosis of squamous cell carcinoma of the oropharynx, larynx, or hypopharynx. Squamous cell carcinoma of unknown primary is not allowed.
  2. * 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.
  3. * Patients may undergo a diagnostic or therapeutic transoral resection for a T1-2 tonsil or base of tongue cancer.
  4. * Clinical stage I-IVB (AJCC, 7th edition); stages I-II glottic cancer are excluded
  5. * Age ≥ 18 years.
  6. * ECOG Performance Status 0-2
  7. * 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.
  8. * 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).
  9. * Neck CT and/or neck MRI, and PET-CT
  10. * Ability to understand and the willingness to sign a written informed consent.
  1. * Distant metastasis. Inability to undergo either a diagnostic CT with contrast or simulation CT with contrast.
  2. * Inability to undergo PET-CT.
  3. * Stage I and II glottic carcinoma.
  4. * Gross total excision of both the primary and nodal disease.
  5. * 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.
  6. * Prior invasive malignancy with an expected disease-free interval of less than 3 years.
  7. * Prior systemic chemotherapy for the study cancer; prior chemotherapy for a remote cancer is allowable.
  8. * Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields.
  9. * Subjects may not be receiving any other investigational agents.
  10. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to the chemotherapy agents in this study (if necessary).
  11. * 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.
  12. * History of severe immunosuppression, including HIV, and organ or autologous or allogeneic stem cell transplant.

Contacts and Locations

Study Contact

Sarah Neufeld
CONTACT
214-645-8525
Sarah.hardee@utsouthwestern.edu
Liliana Robles
CONTACT
214-645-8525
liliana.robles@utsouthwestern.edu

Principal Investigator

David Sher, MD
PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medical Center

Study Locations (Sites)

UT Southwestern Medical Center
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-14
Study Completion Date2028-07-01

Study Record Updates

Study Start Date2024-11-14
Study Completion Date2028-07-01

Terms related to this study

Additional Relevant MeSH Terms

  • Head and Neck Cancer