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Treatment for Locally Advanced Head and Neck Cancer
Untitled Document
Name of the Trial
Phase III Randomized Study of Concurrent Accelerated Fractionated Radiotherapy
and Cisplatin With Versus Without Cetuximab in Patients With Stage III or IV
Squamous Cell Carcinoma of the Oropharynx, Hypopharynx, or Larynx (RTOG-0522).
See the protocol summary.
Principal Investigator
Dr. K. Kian Ang, Radiation Therapy Oncology Group.
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Dr. K. Kian Ang
Principal Investigator |
Why This Trial Is Important
Recent clinical trials have shown that treating locally advanced head and neck
cancer with combined chemotherapy and radiation therapy helps patients live
longer than if they are treated with radiotherapy alone.
This trial will enroll patients with locally advanced squamous cell carcinoma
of the larynx, oropharynx, or hypopharynx. "Locally advanced" means
that the cancer has spread to nearby tissues or lymph nodes but not elsewhere.
All patients will be treated with radiotherapy and the chemotherapy drug cisplatin.
In addition, half of the patients will be treated with a monoclonal antibody
called cetuximab.
Cetuximab targets a protein called epidermal growth factor receptor (EGFR),
which is found in excess amounts on the surface of many cancer cells. Blocking
the activity of EGFR may inhibit a tumor's ability to grow. In a previous trial,
adding cetuximab to radiotherapy significantly improved the survival of patients
with locally advanced head and neck cancer (see related
article). Researchers want to know if adding cetuximab to radiotherapy and
cisplatin treatment will help patients live longer without their cancer recurring.
"Earlier trials have proven that combining radiation with either cisplatin
or cetuximab decreases the likelihood of recurrence," said Dr. Ang. "With
this trial, we hope to see if combining radiation with both agents further improves
disease-free survival."
Who Can Join This Trial
Researchers will recruit 720 patients aged 18 or over with stage III or stage
IV squamous cell carcinoma of the oropharynx, hypopharynx, or larynx with no
distant metastases. See the list
of eligibility criteria. This trial is eligible for special
Medicare coverage.
Study Site and Contact Information
Multiple study sites in the United States are recruiting patients for this
trial. See the list
of study sites or call the NCI's Cancer Information Service at 1-800-4-CANCER
(1-800-422-6237) for more information. The toll-free call is confidential.
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