28 Participants Needed

Chemotherapy + Reduced-Dose Radiation for Throat Cancer

(ENID Trial)

JC
MC
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Overseen ByGregory Biedermann, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Missouri-Columbia
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 trial will explore giving standard dose chemotherapy and radiation therapy to sites of disease including all lymph nodes involved with HPV-positive oropharyngeal cancer, but administer lower doses of radiation therapy to the lymph nodes that are not known to be involved with cancer. By doing so, it is hypothesized that there will be equally good long term loco-regional and distant disease control but will reduced long term treatment side effects and improved quality of life in persons living well beyond their cancer treatment.

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 trial coordinators or your doctor.

Is the combination of chemotherapy and reduced-dose radiation safe for throat cancer?

The combination of chemotherapy (cisplatin) and radiation therapy has been studied for head and neck cancers, showing some safety concerns. Patients experienced severe nausea, vomiting, and other side effects, but overall, the treatment was considered effective and generally well-tolerated in some studies, with gastrointestinal and blood-related side effects being the most common.12345

How is the treatment of chemotherapy combined with reduced-dose radiation for throat cancer different from other treatments?

This treatment is unique because it combines chemotherapy with a reduced dose of radiation, potentially minimizing side effects while maintaining effectiveness. Cisplatin is often used in combination with radiation for head and neck cancers, but this approach specifically aims to reduce radiation exposure, which may lead to fewer long-term complications compared to standard radiation doses.678910

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

Research shows that using cisplatin with radiation therapy, like in the RADPLAT protocol, can effectively control tumors in head and neck cancers, offering promising survival rates and preserving organ function.78111213

Who Is on the Research Team?

Gregory Biedermann, MD - MU Health Care

Gregory Biedermann, MD

Principal Investigator

University of Missouri - Ellis Fischel Cancer Center

Are You a Good Fit for This Trial?

This trial is for low-risk patients with HPV-positive oropharyngeal cancer who have not had prior invasive malignancies (except certain skin cancers) in the last 5 years, no previous radiotherapy overlapping the study area, and no chemotherapy for their current cancer. They must be generally healthy, non-heavy smokers or willing to quit, and women of childbearing age should use contraception.

Inclusion Criteria

I have been diagnosed with a specific type of throat cancer.
I've had a throat exam using a special scope within the last 60 days.
I have had an MRI of the neck with contrast and a chest CT scan.
See 23 more

Exclusion Criteria

My cancer is in the early stages and located in my tonsil.
My cancer originates from the mouth, nasopharynx, hypopharynx, or larynx.
I have been cancer-free for at least 5 years, except for non-melanoma skin cancer.
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemoradiation Treatment

Participants receive concurrent cisplatin and radiation therapy with dose de-escalation to uninvolved lymph nodes

6 weeks
Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including survival and toxicity profiles

2 years
Visits at 1 month, 6 months, 1 year, and 2 years post-treatment

What Are the Treatments Tested in This Trial?

Interventions

  • Cisplatin
  • Radiation Therapy
Trial Overview The trial tests if giving standard dose chemotherapy alongside radiation therapy directly to areas affected by HPV-positive oropharyngeal cancer—and lower doses to unaffected lymph nodes—can control the disease while reducing long-term side effects and improving life quality after treatment.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Open label single-arm studyExperimental Treatment1 Intervention

Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:

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Approved in European Union as Platinol for:
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Approved in United States as Platinol for:
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Approved in Canada as Platinol for:
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Approved in Japan as Platinol for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials
387
Recruited
629,000+

Published Research Related to This Trial

In a phase II trial involving 32 patients with advanced head and neck cancer, the aggressive combination of cisplatinum and paclitaxel with hyperfractionated-accelerated radiotherapy resulted in a 5-year overall survival rate of 48% and a disease-free survival rate of 43%.
While the treatment showed promising response rates, with 69% achieving a complete response, it was associated with significant acute toxicities, including high rates of grade 3 mucositis (71%) and erythema (28%), indicating the need for extensive supportive care during treatment.
Phase II trial of a simultaneous radiochemotherapy with cisplatinum and paclitaxel in combination with hyperfractionated-accelerated radiotherapy in locally advanced head and neck tumors.Kuhnt, T., Becker, A., Bloching, M., et al.[2022]
The RADPLAT approach, which combines supradose intra-arterial cisplatin chemotherapy with radiotherapy, shows promising survival rates and high locoregional tumor control in patients with advanced head and neck squamous cell carcinoma.
This method not only demonstrates acceptable toxicity but also helps preserve organ function, addressing significant concerns associated with traditional surgical treatments.
Treatment of advanced head and neck cancer with intra-arterial cisplatin and concurrent radiation therapy: the 'RADPLAT' protocol.Kumar, P., Robbins, KT.[2019]
In a study comparing cisplatin and cetuximab added to radiation therapy for head and neck squamous cell carcinoma, patients receiving cisplatin had a significantly higher 3-year disease-specific survival rate of 83% compared to 31% for those receiving cetuximab.
Cisplatin treatment was associated with a lower recurrence rate of disease (4 patients) compared to cetuximab (17 patients), indicating that cisplatin may be more effective in improving outcomes when combined with radiation therapy.
Cisplatin versus cetuximab given concurrently with definitive radiation therapy for locally advanced head and neck squamous cell carcinoma.Ley, J., Mehan, P., Wildes, TM., et al.[2021]

Citations

Phase II trial of a simultaneous radiochemotherapy with cisplatinum and paclitaxel in combination with hyperfractionated-accelerated radiotherapy in locally advanced head and neck tumors. [2022]
Treatment of advanced head and neck cancer with intra-arterial cisplatin and concurrent radiation therapy: the 'RADPLAT' protocol. [2019]
Cisplatin versus cetuximab given concurrently with definitive radiation therapy for locally advanced head and neck squamous cell carcinoma. [2021]
Carboplatin-based concurrent chemoradiation therapy in locally advanced head and neck cancer patients who are unfit for cisplatin therapy. [2018]
Concurrent intra-arterial chemotherapy and radiotherapy for advanced laryngeal cancer. [2018]
Concomitant radiation therapy and cis-diamminedichloroplatinum (II) in patients with advanced head and neck cancer. [2019]
Platinum-based concurrent chemoradiotherapy for tumors of the head and neck and the esophagus. [2005]
Weekly paclitaxel and cisplatin with concurrent radiotherapy in locally advanced non-small-cell lung cancer: a phase I study. [2017]
Simultaneous cis-platinum and radiotherapy in inoperable or locally advanced squamous cell carcinoma of the head and neck. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Radiotherapy and chemotherapy in locally advanced non-small cell lung cancer: preclinical and early clinical data. [2019]
Carboplatin in combination with raltitrexed in recurrent and metastatic head and neck squamous cell carcinoma: A multicentre phase II study of the Gruppo Oncologico Dell'Italia Meridionale (G.O.I.M.). [2014]
In squamous cell head and neck cancer: which platinum, how much and how often? [2019]
13.United Statespubmed.ncbi.nlm.nih.gov
Preoperative simultaneous fractionated cisplatin and radiation therapy in the treatment of advanced operable stage III and IV squamous cell carcinoma of the head and neck. [2019]
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