Radiation Therapy + Cetuximab for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

+263 other locations

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

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

RATIONALE: Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor, and giving radiation therapy in higher doses over a shorter period of time, may kill more tumor cells and have fewer side effects. 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 when given alone or together with cetuximab in treating patients with head and neck cancer that has been removed by surgery. PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with cetuximab in treating patients who have undergone surgery for locally advanced head and neck cancer.

Research Team

Mitchell Machtay, MD

Principal Investigator

Milton S. Hershey Medical Center, Penn State Health

Eligibility Criteria

This trial is for individuals who've had surgery for locally advanced head and neck cancer, specifically squamous cell carcinoma. They should be in the early stages of the disease (T1, N1-2, M0 or T2-4a, N0-2, M0) and have 'intermediate' risk of recurrence. People with a history of other cancers within 5 years (except certain skin cancers), lymphoproliferative disorders, or living outside the US cannot participate.

Inclusion Criteria

I had surgery to remove my tumor completely within the last 7 weeks, aiming for a cure.

I have been diagnosed with squamous cell carcinoma in the head or neck.

My cancer is in an early stage but may have spread to nearby lymph nodes.

Exclusion Criteria

I have had a condition where my lymphocytes grow abnormally.

I haven't had cancer in the last 5 years, except for skin cancer.

I have a history of cancer.

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Treatment Details

Interventions

Cetuximab (Monoclonal Antibodies)
Intensity-Modulated Radiation Therapy (Radiation)

Trial OverviewThe study is examining if adding cetuximab to intensity-modulated radiation therapy (IMRT) improves outcomes compared to IMRT alone after surgery. It's a phase III trial where patients are randomly assigned to either receive radiation only or radiation plus cetuximab.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II: IMRT plus cetuximabExperimental Treatment2 Interventions

Radiation therapy (RT): 60 Gy IMRT, 2 Gy/day in 30 fractions (5 days a week for 6 weeks). Cetuximab: 400 mg/m\^2 intravenously (IV) at least 5 days prior to IMRT; 250 mg/m\^2 IV once a week for 6 weeks during RT and continuing 4 weeks after RT.

Group II: Arm I: Intensity-Modulated RadiotherapyActive Control1 Intervention

Radiation therapy: 60 Gy intensity-modulated radiotherapy (IMRT), 2 Gy/day in 30 fractions (5 days a week for 6 weeks).

Intensity-Modulated Radiation Therapy is already approved in Canada for the following indications: