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Alkylating agents

IMRT +/− Cisplatin for Oropharyngeal Cancer

Phase 2

Waitlist Available

Led By Sue Yom

Research Sponsored by NRG Oncology

Eligibility Criteria Checklist

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

Must have

Age ≥ 18

p16 positive by immunohistochemistry confirmed by central pathology review

Must not have

Metastatic disease or adenopathy below the clavicles

Cancers from oral cavity, nasopharynx, hypopharynx, or larynx

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year post-rt. radiation therapy (rt) ends at approximately 6 weeks for arm 1 and 5 weeks for arm 2

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying IMRT with or without cisplatin to see how well it works in treating patients with oropharyngeal cancer.

Who is the study for?

This trial is for adults with advanced oropharyngeal cancer, which includes cancers of the mouth and throat. Participants must have a specific type of squamous cell carcinoma confirmed by pathology, measurable disease, and positive p16 immunohistochemistry. They should be in good physical condition (Zubrod Performance Status 0-1), not exceed a 10 pack-year smoking history, and have proper organ function. HIV-positive patients can join if they meet certain health criteria.

What is being tested?

The study is testing whether reduced-dose intensity-modulated radiation therapy (IMRT) alone or combined with cisplatin chemotherapy is effective in treating advanced oropharyngeal cancer. Patients will be randomly assigned to receive either IMRT for 5 or 6 weeks with or without cisplatin to compare treatment outcomes.

What are the potential side effects?

Potential side effects include those common to radiation therapy such as skin irritation, fatigue, dry mouth, difficulty swallowing, and loss of appetite. Cisplatin may cause additional effects like nausea, kidney damage, hearing loss, nerve problems and an increased risk of infection.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My cancer is p16 positive.

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I have been diagnosed with squamous cell carcinoma in my throat.

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My cancer is in an early to mid-stage, not spread widely.

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My cancer tissue has been tested for p16.

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My cancer can be seen or measured on scans.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread beyond its original site or I have swollen lymph nodes below my collarbone.

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My cancer originates from the mouth, nose, throat, or voice box.

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My cancer has spread to the lymph nodes near my collarbone.

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I have not had any other cancer besides this one in the last 3 years.

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I have received chemotherapy for my current cancer.

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I've had radiation in the same area as my current cancer.

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I have more than one primary cancer or tumors in both sides of a body part.

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I had surgery to remove all visible cancer from the primary and nodal sites.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year post-rt. radiation therapy (rt) ends at approximately 6 weeks for arm 1 and 5 weeks for arm 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year post-rt. radiation therapy (rt) ends at approximately 6 weeks for arm 1 and 5 weeks for arm 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year post-rt. radiation therapy (rt) ends at approximately 6 weeks for arm 1 and 5 weeks for arm 2 for reporting.