IMRT +/− Cisplatin for Oropharyngeal Cancer

Recruiting at258 trial locations

Overseen by Sue 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.

Research Team

Sue Yom

Principal Investigator

NRG Oncology

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 fully active or restricted in physically strenuous activity but can do light work.

My blood, kidney, and liver tests are normal.

Imaging within 56 days prior to registration

Exclusion Criteria

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

I have received chemotherapy for my current cancer.

Prior allergic reaction to cisplatin

Treatment Details

Interventions

• Cisplatin (Alkylating agents)
• Intensity-Modulated Radiation Therapy (Radiation)

Trial Overview 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.

Participant Groups

Group I: IMRT 6 weeks + cisplatin Experimental Treatment 2 Interventions

IMRT 6 weeks with concurrent cisplatin

Group II: IMRT 5 weeks Experimental Treatment 1 Intervention

IMRT 5 weeks

Cisplatin is already approved in Canada, Japan for the following indications:

Approved in Canada as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in Japan as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Who Is Running the Clinical Trial?

NRG Oncology

Lead Sponsor

Trials

242

Recruited

105,000+

Stephanie Gaillard

NRG Oncology

Chief Medical Officer

MD from Johns Hopkins University

Norman Wolmark

NRG Oncology

Chief Executive Officer since 2023

MD from Harvard Medical School

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School