Avastin and Doxorubicin Postoperatively for Patients With Anaplastic Thyroid Cancer
This trial is active, not recruiting.
|Conditions||thyroid neoplasms, carcinoma, thyroid cancer, metastatic cancer|
|Start date||April 2008|
|End date||December 2012|
|Trial size||30 participants|
|Trial identifier||NCT00804830, 2007-001783-75|
Anaplastic Thyroid Cancer is a very aggressive disease. The investigators believe that angiogenesis is very important for these tumors to progress. Preclinical data is suggesting this. This is why we we prospectively want to treat these patients with avastin (and doxorubicin). However, local control is of major concern. Therefore, patients are initially treated with hyperfractionated radiotherapy and undergo surgery. Then they can enter this study.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Göteborg, Sweden||Jubileumskliniken, Sahlgrenska universitetsjukhuset||no longer recruiting|
|Lund, Sweden||Dep of Oncology, Lund University Hospital||no longer recruiting|
|Stockholm, Sweden||Karolinska University Hospital||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
Treatment with Avastin 15 mg/kg q3w and doxorubicin 20 mg q1w for 6 months.
time frame: 2-5 years
time frame: 2-5 years
Male or female participants of any age.
Inclusion Criteria: - cytologically or histologically verified anaplastic thyroid cancer - completed standard therapy - operated with R0 or R1 surgery - Performance Status 0-2 (if pulmonary mets PS 0-1) - normal wound healing - neutrophils > 1,5 million/ml - platelets > 100 million/ml - bilirubin < 2 ULN - creatinin < 150mikromol/L Exclusion Criteria: - PS 3-4 (if pulmonary mets 2-4) - R2 resection of primary tumor
|Official title||Phase 2 Study With Avastin and Doxorubicin Postoperatively for Patients With Anaplastic Thyroid Cancer|
|Principal investigator||Jan Tennvall, MD, PhD|
|Description||Patients with Anaplastic Thyroid Cancer have a poor prognosis. We will treat the patients initially with our standard radiochemotherapy, which consists of doxorubicin 20mg fixed dose/week and hyperfractionated radiotherapy 1,6 Gy twice daily up to 46 Gy in total. The first week during radiotherapy, they will also receive Avastin 15mg/kg. 1-2 weeks after radiotherapy patients will undergo surgery of their primary tumor. After this "standard" therapy patients can be included in this study. Treatment is 20 mg fixed dose doxorubicin q1w and avastin 15mg/kg q3w. Treatment will continue maximum 6 months or until progress or until intolerable side effects occur.|
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