ACTIVE_NOT_RECRUITING

Pilot Trial of Adaptive Radiotherapy Boost for HNSCC

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Conditions

Squamous Cell CarcinomaHead 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

The purpose of the study is to determine if it is feasible to use magnetic resonance imaging (MRI) to adjust a portion of radiation therapy for patients with head and neck squamous cell carcinoma . The technique under study will be used to personalize the study treatment based on response, keeping all treatments within standard of care guidelines.

Official Title

Pilot Trial of Adaptive Radiotherapy Boost for Head and Neck Squamous Cell Carcinomas

Quick Facts

Study Start:2023-12-14
Study Completion:2026-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06137274

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provision of signed and dated informed consent form
  2. * Stated willingness to comply with all study procedures and availability for the duration of the study
  3. * ECOG performance status of 0, 1
  4. * Patients with histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, or unknown primary in the neck.
  5. * Patients with measurable disease, either at primary site or neck per RECIST 1.1.
  6. * For patients planned to receive chemotherapy, adequate hematologic, hepatic and renal function as outlined in protocol.
  7. * International normalized ratio of prothrombin time (INR) and prothrombin time (PT) within 28 days before randomization must be WNL for the lab. Patients who are therapeutically treated with an agent such as warfarin may participate if they are on a stable dose and no underlying abnormality in coagulation parameters exists per medical history.
  8. * Negative serum pregnancy test within before starting study treatment in woman with childbearing potential.
  1. * Pregnancy or lactation
  2. * Patients who have had prior radiotherapy to the head and neck or prior systemic therapy for the index cancer.
  3. * Patients who had undergone definitive surgery for the index cancer.
  4. * Patients with distant metastatic disease
  5. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.

Contacts and Locations

Principal Investigator

George Yang, MD
PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center

Study Locations (Sites)

Moffitt Cancer Center
Tampa, Florida, 33612
United States

Collaborators and Investigators

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

  • George Yang, MD, PRINCIPAL_INVESTIGATOR, Moffitt Cancer 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 Date2023-12-14
Study Completion Date2026-11

Study Record Updates

Study Start Date2023-12-14
Study Completion Date2026-11

Terms related to this study

Additional Relevant MeSH Terms

  • Squamous Cell Carcinoma
  • Head and Neck Cancer