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Chemotherapy

Treatment Arm for Oropharyngeal Cancer (ARTHOUSE Trial)

Phase 2

Recruiting

Led By Michelle Mierzwa

Research Sponsored by University of Michigan Rogel Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >18

AJCC 8 Stage III (cT4 or N3)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years from start of treatment

Awards & highlights

ARTHOUSE Trial Summary

This trial wants to understand more about patients with a type of throat cancer caused by the HPV virus. They want to identify the patients who are at the highest risk of the cancer coming back after treatment.

Who is the study for?

This trial is for adults over 18 with advanced HPV-related squamous cell carcinoma of the oropharynx, specifically stage III (cT4 or N3). Participants must be in good physical condition (ECOG 0-1), have certain blood and liver function levels within normal ranges, and be able to receive chemotherapy. Women who can bear children and men must use effective birth control during the study.Check my eligibility

What is being tested?

The study is testing whether using detailed imaging techniques like DCE MRI and FDG-PET to guide radiation therapy can improve outcomes for high-risk throat cancer patients while maintaining or reducing treatment side effects compared to standard therapies.See study design

What are the potential side effects?

Potential side effects include those commonly associated with radiation therapy such as skin irritation, fatigue, dry mouth, difficulty swallowing, and nausea. Chemotherapy may cause additional risks like hair loss, anemia, increased infection risk due to low white blood cell counts.

ARTHOUSE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am older than 18.

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My cancer is at an advanced stage but has not spread to distant organs.

Select...

My throat cancer is advanced, p16 positive, and I am referred for chemo and radiation.

ARTHOUSE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years from start of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years from start of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years from start of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Toxicity of treatment based off of Adverse Events collected per CTCAE v5.0

Secondary outcome measures

Biomarker analysis from tumor tissue, to compile biomarker information

Local regional recurrence free survival

MRIs and FDG PET scans- efficacy and toxicity

+4 more

ARTHOUSE Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment ArmExperimental Treatment2 Interventions

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation

2003

Completed Phase 3

~1020

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Michigan Rogel Cancer CenterLead Sponsor

294 Previous Clinical Trials

24,241 Total Patients Enrolled

Michelle MierzwaPrincipal InvestigatorUniversity of Michigan Rogel Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this medical study currently accepting new participants?

"Indeed, the information provided on clinicaltrials.gov indicates that this trial is actively seeking eligible candidates. It was initially posted on December 20th, 2023 and recently updated on January 22nd, 2024. The study aims to recruit a total of 20 participants from one designated location."

Answered by AI

What is the level of risk associated with the Treatment Arm for patients?

"Based on our evaluation at Power, the safety level of the Treatment Arm is rated as 2. This assessment aligns with it being a Phase 2 trial where there is limited data supporting its safety but no evidence yet regarding efficacy."

Answered by AI

What is the current number of participants being recruited for this research study?

"Indeed, the information available on clinicaltrials.gov indicates that this study is currently in the process of recruiting eligible participants. The trial was initially posted on December 20th, 2023 and received its most recent update on January 22nd, 2024. To complete the study successfully, researchers aim to enroll a total of 20 individuals from one designated location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Trial of Individualized Adaptive RT in HPV-related High Risk Oropharynx Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06234748.