RECRUITING

Induction Chemotherapy Response-Guided Radiation for EBV-Associated Nasopharyngeal Carcinoma

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Conditions

Nasopharyngeal CarcinomaStage III Nasopharyngeal Carcinoma AJCC v8Stage IVA Nasopharyngeal Carcinoma AJCC v8Nasopharyngeal CancerNasopharyngeal Cancer StageHHV-4 PositiveEBV Positivehuman herpesvirus 4 (HHV-4) positive

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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 clinical trial tests the effect of induction chemotherapy response-guided radiation (de-escalated intensity-modulated radiation therapy \[IMRT\]) compared to standard IMRT in patients with Epstein-Barr virus (EBV)-associated nasopharyngeal cancer. Intensity-modulated radiation therapy (IMRT) is an advanced form of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Radiation therapy sometimes causes unwanted symptoms or side effects, including late effects such as hearing loss and dental problems. The severity of the side effects is related to the radiation dose received and the amount of tissue that received radiation. De-escalation IMRT uses lower doses of radiation based on a good response to induction chemotherapy. Giving de-escalated IMRT may be as effective as standard doses of IMRT in treating patients with EBV-associated nasopharyngeal cancer.

Official Title

Induction Chemotherapy Response-Guided Radiation for EBV-Associated Nasopharyngeal Carcinoma

Quick Facts

Study Start:2025-03-18
Study Completion:2032-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06682442

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. * Participants must have histologically or cytologically confirmed (from primary lesion and/or lymph nodes) nasopharyngeal carcinoma.
  2. * Participants must have Epstein Barr virus (EBV)-associated nasopharyngeal carcinoma, defined as detectable (\> 0 copies/mL) circulating plasma EBV DNA on a qualitative or quantitative polymerase chain reaction (PCR)-based test.
  3. * Stage III-IVA disease (American Joint Committee on Cancer \[AJCC\], 8th edition \[ed.\]) with no evidence of distant metastasis at the time of diagnosis based upon all 3 of the following minimum diagnostic workup criteria:
  4. * History/physical examination by a medical oncologist or clinical oncologist or radiation oncologist or otolaryngology (ENT);
  5. * Evaluation of tumor extent with either one of the following:
  6. * MRI with contrast of the face, nasopharynx, and neck or CT with contrast of the face, nasopharynx and neck with ≤ 3 mm contiguous slices and bone windows to evaluate base of skull involvement; or
  7. * MRI of the nasopharynx and PET/CT (with contrast) of the neck
  8. * Imaging to rule out distant metastasis:
  9. * CT scan with contrast of the chest and abdomen (required) and the pelvis (optional) or a total body PET/CT scan (non-contrast PET/CT is acceptable); and
  10. * Only if clinically indicated: Bone scan only when there is suspicion of bone metastases (a PET/CT scan can substitute for the bone scan)
  11. * Completed platinum-based induction systemic therapy.
  12. * Planning to receive intensity modulated radiation therapy (IMRT) with concurrent, platinum-based systemic therapy during radiation.
  13. * Use of adjuvant (post-chemoradiation) immunotherapy is permitted.
  14. * Age \>=18 years.
  15. * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 50%).
  16. * Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy are eligible for this trial.
  17. * For individuals with evidence of chronic hepatitis B virus (HBV) infection: must be on suppressive therapy, if indicated.
  18. * For individuals with a history of hepatitis C virus (HCV) infection: must be currently on treatment, or must have been treated and cured.
  19. * Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  20. * Because the radiation therapy used in this trial is known to be teratogenic, individuals of reproductive potential must agree to use adequate contraception (e.g., hormonal or barrier methods, abstinence) for the duration of study participation and for at least 60 days after the last administration of radiation therapy. Should a study participant or their partner become pregnant or suspect pregnancy while participating in this study, they should inform their treating physician immediately.
  21. * Ability to understand and willingness to sign a written informed consent document.
  1. * Prior systemic chemotherapy for nasopharyngeal carcinoma, other than induction chemotherapy (IT); note that prior chemotherapy for a different cancer is permitted
  2. * Prior radiotherapy to the nasopharynx or surrounding involved areas that would result in overlap of radiation therapy fields
  3. * Has participated in a study of an investigational product and received treatment with an investigational drug or used an investigational device within 4 weeks prior to the first dose of treatment
  4. * Severe, active comorbidity, defined as any of the following:
  5. * Major medical or psychiatric illness that, in the treating investigator's opinion, would interfere with the completion of therapy and follow-up or interfere with a full understanding of the risks and potential complications of the therapy
  6. * Unstable angina, congestive heart failure, or peripheral vascular disease requiring hospitalization within the last 12 months; or other cardiac compromise that in the judgment of the treating investigator will preclude safe administration of study treatment
  7. * Chronic obstructive pulmonary disease (COPD) exacerbation or other respiratory illness requiring hospitalization within 30 days prior to registration, or which would preclude safe administration study therapy in the opinion of the treating investigator
  8. * Active, untreated infection and/or acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  9. * Because the radiation therapy used in this trial is known to be teratogenic, individuals of child-bearing potential must have documentation in their medical record of a negative pregnancy test
  10. * Has reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause)
  11. * Has undergone surgical sterilization (i.e., hysterectomy and/or bilateral oophorectomy for removal of uterus and/or ovaries)
  12. * Individuals with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study activities or interfere with participant safety or study endpoints

Contacts and Locations

Study Contact

Jamese Johnson
CONTACT
(415) 530-9805
jamese.johnson@ucsf.edu

Principal Investigator

Sue Yom, MD, PhD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco
San Francisco, California, 94143
United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Sue Yom, MD, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

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 Date2025-03-18
Study Completion Date2032-03-31

Study Record Updates

Study Start Date2025-03-18
Study Completion Date2032-03-31

Terms related to this study

Keywords Provided by Researchers

  • HHV-4 Positive
  • EBV Positive
  • human herpesvirus 4 (HHV-4) positive

Additional Relevant MeSH Terms

  • Nasopharyngeal Carcinoma
  • Stage III Nasopharyngeal Carcinoma AJCC v8
  • Stage IVA Nasopharyngeal Carcinoma AJCC v8
  • Nasopharyngeal Cancer
  • Nasopharyngeal Cancer Stage