Thyroid Cancer and Sunitinib (NCT00510640) | Clinical Trial Compass
CompletedPhase 2
Thyroid Cancer and Sunitinib
France71 participantsStarted 2007-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Signed informed consent.
* Age ≥ 18.
* Patients must have a life expectancy of at least 3 months
* Patients must have a Karnofsky performance status ≥ 70%
* Patients must have histologically confirmed thyroid cancer (TC)
* Tumor disease must be progressive (evidence of disease progression within 6 months before starting the study for follicular and medullary thyroid cancer or symptomatic disease)
* Patients should not be candidates for surgical resection, external beam radiotherapy or radioiodine
* Patients must have measurable disease defined by Response Evaluation Criteria in Solid Tumors (RECIST), such as at least one lesion at least 2 cm in length by conventional computed tomography (CT) techniques or at least 1 cm by spiral CT scan
* Patients must not have more than one previous systemic treatment for cancer
* Resolution of all acute toxic effects of any prior local treatment to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 3.0) grade \< 1
* Patients must have discontinued from radiation therapy at least 4 weeks before start of study treatment and must have recovered from any toxic effects of treatment
* Blood pressure \< 140 / 90 mmHg
* Patients must have adequate organ function defined as: Platelets \> 100 x 10\*9/L, Hemoglobin \> 8 g/dl, ANC \> 1.5 x 10\*9/L, Bilirubin \< 3 mg/dL, AST and ALT \< 2.5 x the upper limit of normal (ULN) or \< 5 x the ULN for liver metastases, INR \< 1.7 or prothrombin …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective response rate (ORR) : defined as the proportion of patients with confirmed complete (CR) or partial response (PR) according to the RECIST, relative to the total patients enrolled who received at least 1 dose of trial medication