RT With or Without Cetuximab in Treating Patients Who Have Undergone Surgery for Locally Advanced Head and Neck Cancer

Conditions

• Head and Neck Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• cetuximab — BIOLOGICAL
  intravenously
• intensity-modulated radiation therapy — RADIATION
  daily fractions

Study Details

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.

Key Dates

First listed

Aug 11, 2009

Start date

Mar 31, 2010

Status verified

Jul 2025

Primary completion

Sep 5, 2023

Completion

Aug 31, 2029

Study Design

Enrollment

702 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm I: Intensity-Modulated Radiotherapy
  Radiation therapy: 60 Gy intensity-modulated radiotherapy (IMRT), 2 Gy/day in 30 fractions (5 days a week for 6 weeks).
• Experimental: Arm II: IMRT plus cetuximab
  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.

Primary Outcome Measure

Percentage of Participants Alive (Overall Survival) [ Time Frame: From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years. ]

Locations (250)

Find similar trials in Birmingham, AL

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