Radiation + Drug for Oropharyngeal Cancer

Recruiting at184 trial locations

Overseen by Maura Gillison, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Radiation Therapy Oncology Group

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether radiation therapy is more effective with cisplatin or cetuximab in treating oropharyngeal cancer. PURPOSE: This phase III trial is studying radiation therapy with cisplatin or cetuximab to see how well it works in treating patients with oropharyngeal cancer.

Research Team

Andy M. Trotti, MD

Principal Investigator

H. Lee Moffitt Cancer Center and Research Institute

Maura Gillison, MD, PhD

Principal Investigator

Ohio State University

Eligibility Criteria

Adults with oropharyngeal cancer, specifically squamous cell carcinoma, who haven't had prior chemotherapy or radiotherapy for it. They should have a good performance status and no severe health issues like recent heart attacks or uncontrolled infections. HIV-positive patients can join if they don't have AIDS-defining conditions.

Inclusion Criteria

I am 18 years old or older.

Complete blood count (CBC)/differential obtained within 2 weeks prior to registration

My liver and kidneys are working well.

Exclusion Criteria

I have received chemotherapy for my current cancer.

I have had radiation in the same area where my current cancer is located.

All of my cancer and affected lymph nodes have been surgically removed.

Treatment Details

Interventions

• Cetuximab (Monoclonal Antibodies)
• Cisplatin (Alkylating agents)
• IMRT (Radiation)

Trial Overview This trial is testing whether radiation therapy combined with either cisplatin (a chemotherapy drug) or cetuximab (a monoclonal antibody that targets cancer cells) is more effective in treating patients with cancers of the throat area.

Participant Groups

Group I: IMRT + Cisplatin Active Control 2 Interventions

Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin

Group II: IMRT + Cetuximab Active Control 2 Interventions

Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab

Who Is Running the Clinical Trial?

Radiation Therapy Oncology Group

Lead Sponsor

Trials

191

Recruited

64,900+

Dr. Vivek S. Kavadi

Radiation Therapy Oncology Group

Chief Executive Officer

MD from Harvard Medical School, MBA from The Wharton School

Dr. Gita Suneja

Radiation Therapy Oncology Group

Chief Medical Officer

MD from University of Utah School of Medicine

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

NRG Oncology

Collaborator

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