Thyroid NeoplasmsPhase 2NCT00804830
Avastin and Doxorubicin Postoperatively for Patients With Anaplastic Thyroid Cancer
A Phase 2 study testing Bevacizumab in people with Thyroid Neoplasms and Carcinoma, run by Region Skane at 3 sites in Sweden.
Trial summary
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroid Neoplasms, Carcinoma, Thyroid Cancer
- What is being tested?
- Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesSweden
- Study dates
- Apr 2008to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- platelets > 100 million/ml
- bilirubin < 2 ULN
- creatinin < 150mikromol/L
Who cannot join
- PS 3-4 (if pulmonary mets 2-4)
- R2 resection of primary tumor
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Jubileumskliniken, Sahlgrenska universitetsjukhuset
Gothenburg, 413 45
Dep of Oncology, Lund University Hospital
Lund, 221 85
Karolinska University Hospital
Stockholm, 17176
About this study
Official title: Phase 2 Study With 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.
Read the detailed 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.
- Conditions
- Thyroid Neoplasms, Carcinoma, Thyroid Cancer, Metastatic Cancer
- Being tested
- Bevacizumab
- Keywords
- adjuvant, Anaplastic thyroid cancer
- Medical subject headings
- Thyroid Neoplasms, Carcinoma, Neoplasm Metastasis, Thyroid Carcinoma, Anaplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin 15 mg/kg q3w and doxorubicin 20 mg q1w
Avastin 15 mg/kg q3w and doxorubicin 20 mg q1w
| Study group | Role | What they receive |
|---|---|---|
| chemotherapy | Experimental | Treatment with Avastin 15 mg/kg q3w and doxorubicin 20 mg q1w for 6 months. Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: 2-5 years
Secondary outcomes (1)
Response rate
Measured: 2-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2012
- Study completionDec 2014
Why it stopped: lack of response
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NeoplasmsStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Tennvall, MD, PhD, Principal investigator, Dep of Oncology, Lund University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804830
- Sponsor's protocol ID
- 2007-001783-75
- Status last verified
- Aug 2018
- First submitted
- 8 Dec 2008
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study With Avastin and Doxorubicin Postoperatively for Patients With Anaplastic Thyroid Cancer
- ClinicalTrials.gov ID
- NCT00804830
- Acronym / sponsor ID
- 2007-001783-75
- Conditions
- Thyroid Neoplasms, Carcinoma, Thyroid Cancer, Metastatic Cancer
- Keywords
- adjuvant, Anaplastic thyroid cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of response
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- Apr 2008 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chemotherapy | Experimental | Drug: BevacizumabTreatment with Avastin 15 mg/kg q3w and doxorubicin 20 mg q1w for 6 months. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- PS 3-4 (if pulmonary mets 2-4)
- R2 resection of primary tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevacizumabAlso: Avastin 15 mg/kg q3w and doxorubicin 20 mg q1wAvastin 15 mg/kg q3w and doxorubicin 20 mg q1w | Drug | chemotherapy |
Primary outcome
Overall Survival
Time frame: 2-5 years
1 secondary outcome
Response rate
Time frame: 2-5 years
Results and safety
The study was stopped early (reason given: lack of response). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
Related trials for Thyroid Neoplasms
Recruiting
NIRAF-Guided Parathyroid Identification During Thyroidectomy
Hypocalcemia, Hypoparathyroidism
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingObservational study
DICER1-related Pleuropulmonary Blastoma Cancer Predisposition Syndrome: A Natural History Study
Pleuropulmonary Blastoma, Cystic Nephroma
Recruiting
Evaluation of DNA Methylation Signatures for the Diagnosis and Management of Thyroid Nodules
Thyroid Gland Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Tennvall, MD, PhD principal investigator
Dep of Oncology, Lund University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab in people with Thyroid Neoplasms and Carcinoma, run by Region Skane at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: lack of response). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 2-5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018.