Avastin and Doxorubicin Postoperatively for Patients With Anaplastic Thyroid Cancer
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 2 Study With Avastin and Doxorubicin Postoperatively for Patients With Anaplastic Thyroid Cancer|
- Overall Survival [ Time Frame: 2-5 years ] [ Designated as safety issue: No ]
- Response rate [ Time Frame: 2-5 years ] [ Designated as safety issue: No ]
|Study Start Date:||April 2008|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Treatment with Avastin 15 mg/kg q3w and doxorubicin 20 mg q1w for 6 months.
Avastin 15 mg/kg q3w and doxorubicin 20 mg q1w
Other Name: Avastin 15 mg/kg q3w and doxorubicin 20 mg q1w
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.
|Jubileumskliniken, Sahlgrenska universitetsjukhuset|
|Göteborg, Sweden, 413 45|
|Dep of Oncology, Lund University Hospital|
|Lund, Sweden, 221 85|
|Karolinska University Hospital|
|Stockholm, Sweden, 17176|
|Principal Investigator:||Jan Tennvall, MD, PhD||Dep of Oncology, Lund University Hospital|