RECRUITING

De-escalated Radiation for Human Papillomavirus-Positive Squamous Cell Carcinoma of the Oropharynx

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Conditions

HPV Positive Oropharyngeal Squamous Cell Carcinoma

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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

This is a single-arm, observational registry study determining the effects of reduced radiation dose in select patients with human papillomavirus (HPV) positive oropharyngeal cancer.

Official Title

De-escalated Radiation for Human Papillomavirus-Positive Squamous Cell Carcinoma of the Oropharynx

Quick Facts

Study Start:2022-11-03
Study Completion:2026-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05600842

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. * Pathologically (histologically or cytologically) proven (from primary lesion and/or lymph nodes) diagnosis of human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma. HPV-positivity will be defined as tumors that are p16-positive by immunohistochemistry. Numerous studies have demonstrated near 100% agreement between p16 and HPV for patients with oropharyngeal cancer. As such, the use of p16 has been accepted as an appropriate surrogate for HPV status.
  2. * Clinical stage I, II, or III disease (AJCC Eighth Edition); Note: Patients with M1 tumors (distant metastases) are not eligible;
  3. * History/physical examination within 6 weeks prior to registration, including assessment of weight and recent weight loss;
  4. * Age ≥ 18;
  5. * PET/CT within 6 weeks prior to registration;
  6. * Patients must sign a study-specific informed consent form prior to study entry.
  7. * Both men and women and members of all races and ethnic groups are eligible for this trial. Non-English speaking, deaf, hard of hearing and illiterate individuals are eligible for this trial.
  1. * Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years;
  2. * Patients who have had initial surgical treatment other than the diagnostic biopsy of the primary site or nodal sampling of the neck disease are excluded;
  3. * Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable;
  4. * Receipt of prior radiotherapy that would result in overlap with proposed field.

Contacts and Locations

Study Contact

Chao Family Comprehensive Cancer Center University of California, Irvine
CONTACT
877-827-8839
ucstudy@uci.edu
University of California Irvine Medical
CONTACT

Principal Investigator

Allen M Chen, MD
PRINCIPAL_INVESTIGATOR
Chao Family Comprehensive Cancer Center

Study Locations (Sites)

Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, 92868
United States

Collaborators and Investigators

Sponsor: University of California, Irvine

  • Allen M Chen, MD, PRINCIPAL_INVESTIGATOR, Chao Family Comprehensive 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 Date2022-11-03
Study Completion Date2026-11

Study Record Updates

Study Start Date2022-11-03
Study Completion Date2026-11

Terms related to this study

Additional Relevant MeSH Terms

  • HPV Positive Oropharyngeal Squamous Cell Carcinoma