Name of the Trial
Phase III Randomized Study of Radiotherapy, Cisplatin, and Paclitaxel versus Cisplatin-Based Chemotherapy Alone in Patients with Previously Irradiated Unresectable Locally Recurrent Squamous Cell Carcinoma of the Head and Neck (RTOG-0421). See the protocol summary at http://cancer.gov/clinicaltrials/RTOG-0421.

Principal Investigator
Dr. Stuart Wong, Radiation Therapy Oncology Group

Why is This Trial Important?
The initial treatment of head and neck cancer often includes radiotherapy, with or without chemotherapy or surgery. Despite aggressive treatment, however, the risk of recurrent cancer is high. For patients whose head and neck cancer has recurred locally after prior radiation therapy, the optimal treatment is surgical resection. Unfortunately, few of these patients are able to have surgery due to the location and/or size of the tumor.

In this trial, researchers are randomly assigning patients with inoperable, recurrent head and neck cancer who were treated initially with radiotherapy to one of two types of treatment. One group will be treated with concurrent radiotherapy and chemotherapy, and the second group will be treated with chemotherapy alone.

"Chemotherapy is the current standard of care for locally recurrent, previously irradiated head and neck cancer, but such treatment is usually only palliative, not curative," said Dr. Wong. "Results from previous studies have suggested that better local control, and even long-term survival, may be achieved for some patients treated with both chemotherapy and re-irradiation.

"With this trial, we hope to establish the superiority of concurrent re-irradiation and chemotherapy for patients with recurrent head and neck cancer."

Who Can Join This Trial?
Researchers seek to enroll 240 patients aged 18 and over with inoperable, recurrent squamous cell carcinoma of the head and neck who have previously been treated with radiotherapy. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/RTOG-0421.

Where Is This Trial Taking Place?
Study sites in the United States are recruiting patients for this trial. See the list of study sites at http://cancer.gov/clinicaltrials/RTOG-0421.

Contact Information
For more information, see the list of study contacts at http://cancer.gov/clinicaltrials/RTOG-0421, or call the NCI Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The call is toll free and confidential.

An archive of "Featured Clinical Trial" columns is available at http://cancer.gov/clinicaltrials/ft-all-featured-trials.