19 Participants Needed

Chemotherapy + Radiation for Oropharyngeal Cancer

(ARTHOUSE Trial)

MM
Overseen ByMichelle Mierzwa
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Michigan Rogel Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is the combination of chemotherapy and radiation safe for treating oropharyngeal cancer?

The combination of chemotherapy and radiation, particularly with platinum-based drugs like cisplatin and carboplatin, has been used to treat oropharyngeal cancer. While some side effects like bone necrosis and laryngeal edema have been reported, they are generally considered tolerable, and no severe life-threatening toxicities were observed in the studies.12345

How does the chemotherapy and radiation treatment for oropharyngeal cancer differ from other treatments?

This treatment combines platinum-based chemotherapy (using drugs like cisplatin or carboplatin) with radiation, which is more effective than radiation alone for advanced oropharyngeal cancer. Carboplatin may have fewer side effects compared to cisplatin, making it a potential alternative for patients who cannot tolerate cisplatin.14678

What data supports the effectiveness of the treatment for oropharyngeal cancer?

Research shows that combining chemotherapy with radiation can improve outcomes for patients with advanced oropharyngeal cancer. Specifically, using carboplatin with radiation has shown promising results, with some patients experiencing complete remission and the treatment being well tolerated.14678

Who Is on the Research Team?

MM

Michelle Mierzwa, M.D.

Principal Investigator

University of Michigan Rogel Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been mostly active and able to carry out all my pre-disease activities up to two weeks before joining.
I am older than 18.
My cancer is at an advanced stage but has not spread to distant organs.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive radiation therapy with a prescription of 70 Gy to PTVhigh in 35 fractions, along with weekly platinum chemotherapy

7 weeks
35 visits (in-person, daily)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including biomarker analysis and imaging

up to 3 years

Surveillance

Monitoring of HPV ctDNA biomarkers in urine and blood, and oral microbiome analysis

up to 24 months

What Are the Treatments Tested in This Trial?

Interventions

  • Platinum-based chemotherapy
  • Radiation
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment2 Interventions

Platinum-based chemotherapy is already approved in European Union, United States, Canada, Japan for the following indications:

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Approved in European Union as Platinum-based chemotherapy for:
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Approved in United States as Platinum-based chemotherapy for:
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Approved in Canada as Platinum-based chemotherapy for:
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Approved in Japan as Platinum-based chemotherapy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials
303
Recruited
20,700+

Published Research Related to This Trial

In a study of 160 patients with advanced oropharyngeal squamous cell carcinoma treated with carboplatin, paclitaxel, and radiation over 10 years, the overall survival rates were 81.7% at 3 years and 70.7% at 5 years, indicating effective treatment outcomes.
The treatment demonstrated an acceptable side effect profile, with the most common adverse effect being acute dysphagia (75.25%), and only 11.9% of patients experiencing significant hematologic toxicities, suggesting carboplatin may be a safer alternative to cisplatin.
Survival outcomes in patients with oropharyngeal cancer treated with carboplatin/paclitaxel and concurrent radiotherapy.Roskies, M., Kay-Rivest, E., Mascarella, MA., et al.[2018]
In a study of 20 patients with inoperable stage III and IV oral or oropharyngeal cancers, the combination of carboplatin and radiation therapy resulted in a 60% complete remission rate, indicating significant efficacy in treating these advanced cancers.
The treatment was well tolerated, with only 2 patients experiencing severe side effects that required interruptions, suggesting that carboplatin can be safely integrated into chemoradiation regimens for head and neck cancers.
Simultaneous radiochemotherapy in the treatment of inoperable, locally advanced head and neck cancers.Awasthy, BS., Julka, PK., Rath, GK., et al.[2013]
In a study of 1,149 patients with advanced head and neck squamous cell carcinoma, carboplatin-based chemoradiotherapy showed similar cancer-specific mortality rates compared to cisplatin-based therapy, indicating that carboplatin can be an effective alternative for patients unable to receive cisplatin.
Both carboplatin and cisplatin-based chemoradiotherapy were found to be more effective than radiation therapy alone or radiation with cetuximab, suggesting that carboplatin should be further investigated as a viable treatment option for certain patients.
Survival After Definitive Chemoradiotherapy With Concurrent Cisplatin or Carboplatin for Head and Neck Cancer.Xiang, M., Colevas, AD., Holsinger, FC., et al.[2020]

Citations

Survival outcomes in patients with oropharyngeal cancer treated with carboplatin/paclitaxel and concurrent radiotherapy. [2018]
Simultaneous radiochemotherapy in the treatment of inoperable, locally advanced head and neck cancers. [2013]
Survival After Definitive Chemoradiotherapy With Concurrent Cisplatin or Carboplatin for Head and Neck Cancer. [2020]
Concurrent chemoradiation with carboplatin-5-fluorouracil versus cisplatin in locally advanced oropharyngeal cancers: is more always better? [2013]
Comparing outcomes of concurrent chemotherapy regimens in patients 65 years old or older with locally advanced oropharyngeal carcinoma. [2023]
Clinical outcome of oropharyngeal carcinoma treated with platinum-based chemoradiotherapy. [2014]
Triweekly carboplatin as a potential de-intensification agent in concurrent chemoradiation for early-stage HPV-associated oropharyngeal cancer. [2020]
Definitive radiochemotherapy of advanced head and neck cancer with carboplatin and paclitaxel : a phase II study. [2021]
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