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Study Title: A Randomized Phase III Trial of Concurrent Accelerated Radiation and Cisplatin Versus Concurrent Accelerated Radiation, Cisplatin, and Cetuximab (C225) Followed by Surgery for Selected Patients for Stage III and IV Head and Neck Carcinomas
Category: Cancer, General

Currently accepting participants?
Not at this time.

Principal Investigator: Huong Pham
Study Coordinator: Travis Doran
Phone: 206-341-0748
Email: travis.doran@vmmc.org

What is the A Randomized Phase III Trial of Concurrent Accelerated Radiation and Cisplatin Versus Concurrent Accelerated Radiation, Cisplatin, and Cetuximab (C225) Followed by Surgery for Selected Patients for Stage III and IV Head and Neck Carcinomas study?

The purpose of this study is to compare the effects, good and/or bad, of radiation therapy and chemotherapy (cisplatin) with radiation therapy, chemotherapy, and cetuximab (C225) on you and your advanced head and neck cancer to find out which is better. In this study, you will get either radiation and cisplatin or radiation, cisplatin, and C225.

Who can participate?

Eligibility: Eligibility criteria include the following: At least 18 years old Cancer of the oropharynx, hypopharynx, or larynx No distant metastases No previous chemotherapy for this cancer For more information about the eligibility criteria for this trial, contact the study coordinator.

What do I have to do as a study participant?

Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.

Patients in group one will undergo radiation therapy once or twice a day 5-6 days a week for 6 weeks. They will also receive a 1-hour infusion of cisplatin once in weeks 1 and 4 of radiation therapy.

Patients in group two will receive an infusion of cetuximab once a week for 8 weeks. Beginning 1 week after the start of cetuximab, they will also undergo radiation therapy once or twice a day 5-6 days a week for 6 weeks and receive a 1-hour infusion of cisplatin once in weeks 1 and 4 of radiation therapy.

Approximately 9-10 weeks later, some patients in both groups may undergo surgery to remove the tumor.

Quality of life will be assessed periodically. After finishing treatment, patients will be evaluated periodically for 5 years and once a year thereafter.

Study Summary:

A study to evaluate whether the addition of cetuximab to a concurrent radiation-cisplatin regimen will improve disease-free survival in patients with stage III or IV squamous cell carcinoma of the oropharynx, hypopharynx, or larynx.

Detailed Study Description:

(No information)

Study Design: Interventional
Phase of Study: Phase III
Study Type: Interventional
Condition or Study Focus: Head and Neck Cancer
Intervention Type: Drug, radiotherapy, and possible surgery
Intervention Name: Radiation Therapy and concurrent Cisplain with or without cetuximab followed by surgery (if needed)
Gender: Male and Female
Age group: Interventional
Sponsor: Radiation Therapy Oncology Group (RTOG)


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