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

University of Michigan Rogel Cancer Center logo

University of Michigan Rogel Cancer Center

Status and phase

Enrolling
Phase 2

Conditions

HPV-Related Carcinoma
Oropharynx Cancer

Treatments

Drug: Platinum based chemotherapy
Radiation: Radiation

Study type

Interventional

Funder types

Other

Identifiers

NCT06234748
UMCC 2023.006
HUM00231890 (Other Identifier)

Details and patient eligibility

About

This study seeks to study the population of HPV-related oropharynx cancer patients that appear to be at highest risk for treatment failure with loco-regional failure and distant metastases including cT4 or cN3. The study team aims to determine if it is feasible to use multi-modality imaging (both DCE MRI and FDG-PET) to optimize the radiation boost in high risk p16+ OPSCC with similar or decreased toxicity compared to historic standard therapy.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Treatment Arm
Experimental group
Description:
Patients will initially receive a single prescription of 70 Gy to PTVhigh in 35 fractions with RT given once daily, 5 days a week along with weekly platinum (standard therapy). All fields must be treated daily. On days when chemotherapy is given, it will be administered prior to RT. Prescription to high risk PTV will be 70Gy in 35 fractions and to PTV2 will be 56Gy in 35 fractions.
Treatment:
Radiation: Radiation
Drug: Platinum based chemotherapy

Trial contacts and locations

1

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Central trial contact

Michelle Mierzwa

Data sourced from clinicaltrials.gov

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