IMRT +/− Cisplatin for Oropharyngeal Cancer

Recruiting in Palo Alto (17 mi)

+258 other locations

Overseen BySue Yom

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: NRG Oncology

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This randomized phase II trial studies the side effects and how well modestly reduced-dose intensity-modulated radiation therapy (IMRT) with or without cisplatin works in treating patients with oropharyngeal cancer that has spread to other places in the body (advanced). Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether IMRT is more effective with or without cisplatin in treating patients with oropharyngeal cancer.

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

My cancer is p16 positive.

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

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

My cancer tissue has been tested for p16.

My cancer can be seen or measured on scans.

Exclusion Criteria

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

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

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

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

I have received chemotherapy for my current cancer.

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

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

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

Participant Groups

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.

2Treatment groups

Experimental Treatment

Group I: IMRT 6 weeks + cisplatinExperimental Treatment2 Interventions

IMRT 6 weeks with concurrent cisplatin

Group II: IMRT 5 weeksExperimental Treatment1 Intervention

IMRT 5 weeks

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

🇪🇺 Approved in European Union as Platinol for: