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Phase 2 Study With Avastin and Doxorubicin Postoperatively for Patients With Anaplastic Thyroid Cancer

Phase 2
Open (Enrolling)
Thyroid Neoplasms, Carcinoma, Thyroid Cancer, Metastatic Cancer

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Trial Information

Phase 2 Study With Avastin and Doxorubicin Postoperatively for Patients With Anaplastic Thyroid Cancer

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.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

2-5 years

Safety Issue:


Principal Investigator

Jan Tennvall, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dep of Oncology, Lund University Hospital


Sweden: Medical Products Agency

Study ID:




Start Date:

April 2008

Completion Date:

December 2014

Related Keywords:

  • Thyroid Neoplasms
  • Carcinoma
  • Thyroid Cancer
  • Metastatic Cancer
  • adjuvant
  • Anaplastic thyroid cancer
  • Neoplasms
  • Carcinoma
  • Thyroid Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Thyroid Diseases