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Spots Global Cancer Trial Database for Sutent Adjunctive Treatment of Differentiated Thyroid Cancer

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Trial Identification

Brief Title: Sutent Adjunctive Treatment of Differentiated Thyroid Cancer

Official Title: Sutent Adjunctive Treatment of Differentiated Thyroid Cancer

Study ID: NCT00668811

Interventions

SU011248, Sutent

Study Description

Brief Summary: This study is comparing a drug called Sutent with standard of care treatment for people with advanced thyroid cancer. Because advanced thyroid cancer is becoming increasingly common and effective treatment options are limited, new therapies are desperately needed. This study is designed to see if Sutent following therapy with radioactive iodine will target cancer cells and delay disease progression better than standard therapy alone. Newly diagnosed patients, who are scheduled to receive radioactive iodine as part of their standard care are possible candidates. By entering into this study, participants agree to take oral Sutent for approximately two years after completing standard therapy. During this time, study participants will be followed closely by their doctor.

Detailed Description: This is a two-stage, phase II, single center, targeted therapy trial enrolling patients with stage 2 (for patients younger than 45 years of age), 3 or 4 differentiated thyroid cancer. The primary objective is to assess progression free survival in this population. Sutent will be given orally at 37.5mg daily for two (2) year, or 26 cycles. Each treatment cycle will consist of 28 days. Upon treatment discontinuation, patients will be followed for survival. The frequency and type of survival follow-up assessments performed will be at the discretion of the treating physician.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

MedStar Washington Hospital Center, Washington, District of Columbia, United States

Contact Details

Name: Kenneth D Burman, MD

Affiliation: Medstar Health Research Institute

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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