Search / Trial NCT06234748

Trial of Individualized Adaptive RT in HPV-related High Risk Oropharynx Cancer

Launched by UNIVERSITY OF MICHIGAN ROGEL CANCER CENTER · Jan 22, 2024

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Trial Information

Current as of December 21, 2024

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat patients with a specific type of throat cancer called HPV-related oropharynx cancer. The goal is to find out if using advanced imaging techniques can help doctors give a more targeted radiation treatment to patients who are at high risk for their cancer returning or spreading, while also ensuring that side effects are similar or less severe compared to standard treatments.

To be eligible for this study, patients must have a confirmed diagnosis of locally advanced HPV-related throat cancer and meet certain health criteria, including being able to undergo chemotherapy. Participants should be at least 18 years old and must agree to follow safety guidelines, including using effective birth control if applicable. Those who join the trial can expect to receive personalized treatment based on detailed imaging, and they will be closely monitored throughout the process. It’s important for potential participants to understand that this study is exploring new treatment methods, and they will need to provide informed consent before taking part.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • • Patients must have pathologically confirmed, locally/regionally advanced p16+ squamous cell carcinoma of the oropharynx referred for definitive chemo-RT
  • • AJCC 8 Stage III (cT4 or N3)
  • • ECOG 0-1 performance status within two weeks of enrollment
  • • Pre-treatment laboratory criteria within four weeks of enrolment: WBC \> 3500/ul, granulocyte \> 1500/ul. Platelet count \> 100,000/ul. Total Bilirubin \< 1.5 X ULN. AST and ALT \< 2.5 X ULN. Estimated Creatinine clearance \>30cc/min
  • • Patients must be able to receive protocol chemotherapy in the judgment of the treating Medical Oncologist
  • • Age \>18
  • • All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines.
  • • Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study.
  • Exclusion Criteria:
  • • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
  • • Patients should have no contraindications to having a contrast enhanced MRI scan. These contraindications will be assessed at the time of enrollment using the guidelines set up and in clinical use by the Institutional Standard Practice.
  • • Patients should have no contraindications to having a contrast enhanced PET scan. These contraindications will be assessed at the time of enrollment using the guidelines set up and in clinical use by the Institutional Standard Practice.
  • • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
  • • Any prior therapy for the study cancer; note that prior chemotherapy for a different cancer is allowable if \> 3 years prior to study;

Trial Officials

Michelle Mierzwa

Principal Investigator

University of Michigan Rogel Cancer Center

About University Of Michigan Rogel Cancer Center

The University of Michigan Rogel Cancer Center is a leading academic research institution dedicated to advancing cancer treatment and prevention through innovative clinical trials. As a National Cancer Institute-designated Comprehensive Cancer Center, it combines cutting-edge research, state-of-the-art facilities, and a multidisciplinary team of experts to deliver personalized care and foster groundbreaking discoveries. The center's commitment to improving patient outcomes is reflected in its robust portfolio of clinical trials, which explore novel therapies and enhance understanding of cancer biology. Through collaboration with patients, researchers, and healthcare professionals, the Rogel Cancer Center aims to translate scientific insights into transformative therapies, ultimately contributing to the global fight against cancer.

Locations

Ann Arbor, Michigan, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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