Related Links Educational Materials About Clinical Trials Clinical Trials Questions to Ask Your Doctor Drug Information from MedlinePlus

Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase III Randomized Study of Adjuvant Isotretinoin, Interferon alfa, and Vitamin E in Patients With Stage III or IV Squamous Cell Carcinoma of the Head and Neck

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Completed	18 and over	NCI	ECOG-1301 E1301, NCT00054561

Special Category: CTSU trial

Trial Description

Purpose:

Drugs used in chemotherapy such as isotretinoin use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of tumor cells. Vitamin E may be able to decrease side effects caused by isotretinoin. It is not yet known whether combining isotretinoin and interferon alfa with vitamin E is more effective than observation in preventing recurrence of head and neck cancer after surgery and/or radiation therapy.

Randomized phase III trial to compare the effectiveness of isotretinoin and interferon alfa combined with vitamin E with that of observation in treating patients who have undergone surgery and/or radiation therapy for stage III or stage IV head and neck cancer.

Eligibility:

• At least 18 years old
• Disease-free following previous surgery and/or radiation therapy or chemoradiotherapy
• No more than 4 months since surgery and/or radiation therapy or chemoradiotherapy
• At least 4 weeks since chemotherapy
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned to one of two groups.

Patients in group one will receive isotretinoin by mouth once a day, an injection of interferon alfa three times a week, and vitamin E by mouth three times a day. Treatment may be repeated once a month for up to 1 year.

Patients in group two will undergo observation for 1 year.

Patients will be evaluated every 3 months for 2 years and every 6 months for 3 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Dong Shin, MD, Protocol chair		Ph: 404-778-5990; 888-946-7447 Email: dong_shin@emoryhealthcare.org

Registry Information
Official Title		Phase III Randomized Study of Adjuvant Biologic Therapy in Patients with Stages III/IV Head and Neck Squamous Cell Carcinoma
Trial Start Date		2003-08-21
Trial Completion Date		2004-12-20
Registered in ClinicalTrials.gov		NCT00054561
Date Submitted to PDQ		2003-01-16
Information Last Verified		2004-05-07
NCI Grant/Contract Number		U10-CA21115

Back to Top