Thyroid Cancer and Sunitinib
NCT00510640 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 71
Last updated 2026-05-14
Summary
Due to arguments showing that angiogenesis could be involved in progression of metastatic thyroid carcinoma and to objective response during previous studies with sunitinib (an angiogenic oncology drug also known as Sutent), this study, THYSU, is justified to evaluate the efficacy of sunitinib in metastatic thyroid carcinoma. Furthermore, the standard treatment of metastatic thyroid carcinoma when a general treatment is to be prescribed is limited to radioiodine. When radioiodine becomes ineffective, there is no standard treatment despite some use of chemotherapy.
The objective of the trial is to determine the objective tumor response rate (efficacy) in patients with locally advanced or metastatic anaplastic, differentiated or medullary thyroid carcinoma treated with sunitinib; a secondary objective is to evaluate the safety of sunitinib in these patients.
The THYSU trial is a phase II, French multi-center study. This trial's plan is to enroll 75 patients with locally advanced or metastatic anaplastic, differentiated or medullar thyroid carcinoma.
Conditions
- Cancer
- Thyroid Carcinoma
Interventions
- DRUG
-
Sunitinib
Capsule, 12.5 or 50 mg, starting dose level 50 mg daily
Sponsors & Collaborators
- collaborator INDUSTRY
-
University Hospital, Bordeaux
lead OTHER
Principal Investigators
-
Alain Ravaud, Pr. · University Hospital, Bordeaux, France
-
Geneviève Chene, Pr. · University Hospital, Bordeaux, France
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-08-31
- Primary Completion
- 2012-03-31
- Completion
- 2012-03-31
Countries
- France
Study Locations
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