Medullary Thyroid CancerPhase 4NCT01915485
Radiolabeled Molecules for Medullary Thyroid Cancer
A Phase 4 study testing Lu 177 in people with Medullary Thyroid Cancer, run by Instituto Nacional de Cancer, Brazil at 1 site in Brazil.
Trial summary
Medullary thyroid cancer is a neuroendocrine tumour. As so, it has somatostatin receptors in its membrane. Furthermore, very little is available to treat patients who have disease progression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medullary Thyroid Cancer
- What is being tested?
- Lu 177
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2013to Feb 2017
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medullary Thyroid Cancer
- Doubling time calcitonin and CEA less than 6 months
- Measurable disease by cross- sectional imaging
- Irresectable tumors masses
- > 18 years of age
Who cannot join
- < 18 years of age
- Disease that can be treated with new surgical procedure
- Stable disease
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto Nacional do Cancer do Rio de Janeiro
Rio de Janeiro, Rio de Janeiro
Fernanda Vaisman, fvaisman@inca.gov.br
Fernanda Vaisman, MD
About this study
Official title: The Use of Lu177 in the Treatment of Progressive and Unresectable Metastatic Medullary Thyroid Cancer
Medullary thyroid cancer is a neuroendocrine tumour. As so, it has somatostatin receptors in its membrane. Furthermore, very little is available to treat patients who have disease progression. The investigators hypothesized that those tumors may respond to 177-Lu-DOTA Tyr3-octreotate which is a ligand to somatostatin receptors.
Read the detailed description
Medullary thyroid carcinomas can also be located by scintigraphy with 111In-DTPA (diethylenetriamine pentaacetic acid) -octreotide. In some studies, there is a sensitivity for the detection of these tumors by this method, 50-70%. The relationship of calcitonin and carcinoembryonic antigen levels were significantly higher in patients in whom scintigraphy was performed with 111In-DTPA-octreotide. This implies that somatostatin receptors can be detected "in vivo" for different forms of medullary thyroid carcinoma Based on the specific binding of the analogs of somatostatin receptors present on the membrane of some tumors such as medullary thyroid been possible to devise a therapy to target-directed using both beta-emitting radionuclides (which have therapeutic properties) coupled to such molecules. The main radiopharmaceuticals used for this purpose are currently 177 Lu-DOTA-Tyr3-OCTREOTATE or 90Yttrium-DOTA]-TOC.
The medullary thyroid carcinoma (MTC) is a rare neuroendocrine tumor, accounting for only 4.9% of total thyroid carcinomas, however, compared to well differentiated carcinoma, presents a worse prognosis. The tumor staging, and restaging is essential since surgery is the only curative method. Elevated plasma concentrations of calcitonin (CT) and / or high levels of carcinoembryonic antigen (CEA), biochemical markers of MTC, suggest the presence of residual malignant disease / recurrence or metastasis at a distance. After surgery aggressive 40% of patients have persistent disease and about 10%, with undetectable post-surgery CT, develop tumor recurrence. At this point the therapeutic options are scarce and not available in our area. Although the investigators use the structural radiological study using ultrasound, computed tomography and magnetic resonance imaging for staging of the disease, they do not provide functional information. In this context, nuclear medicine examinations can add data such as growth potential and expression pattern of receptors for diagnostic and therapeutic purposes. In 2007, Ong SC. et al. Showed that 18 FDG PET / CT have the ability to detect residual disease, recurrent or metastatic disease with a sensitivity of 78% but only when calcitonin is up 1000pg/ml. Already Iten et al. Using the principle that these tumors express receptors for the somatostatin used OctreoScan ® and subsequent treatment with 90Yttrium-DOTA]-TOC showing not only an advantage for the location of the disease and the possibility of making an image guided therapy by. These authors also demonstrated a clinical benefit to the extent that 25% of the patients showed reduced calcitonin. The investigators hypothesized that those tumors may respond to 177-Lu-DOTA Tyr3-octreotate.
- Conditions
- Medullary Thyroid Cancer
- Being tested
- Lu 177
- Medical subject headings
- Carcinoma, Medullary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu 177Radiation
Patients will be submitted to 4 cycles of 177-Lu with 200mCi each
| Study group | Role | What they receive |
|---|---|---|
| Lu 177 | Experimental | progressive metastatic medullary thyroid cancer Receives: Radiation: Lu 177 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumour Shrinkage
RECIST 1.1 criteria
Measured: 6-8 months
Secondary outcomes (1)
Quality of life improvement
SF 36 pre and post therapy
Measured: 6-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionNov 2016 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medullary Thyroid CancerStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancer, Brazil
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Fernanda Vaisman, MD, PhD, Principal investigator, National Cancer Institute, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915485
- Sponsor's protocol ID
- Lu177-med
- Status last verified
- Sep 2016
- First submitted
- 1 Aug 2013
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Iten F, Muller B, Schindler C, Rochlitz C, Oertli D, Macke HR, Muller-Brand J, Walter MA. Response to [90Yttrium-DOTA]-TOC treatment is associated with long-term survival benefit in metastasized medullary thyroid cancer: a phase II clinical trial. Clin Cancer Res. 2007 Nov 15;13(22 Pt 1):6696-702. doi: 10.1158/1078-0432.CCR-07-0935.
PubMed 18006770
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Lu177 in the Treatment of Progressive and Unresectable Metastatic Medullary Thyroid Cancer
- ClinicalTrials.gov ID
- NCT01915485
- Acronym / sponsor ID
- Lu177-med
- Conditions
- Medullary Thyroid Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Instituto Nacional de Cancer, BrazilOther government
- Study start
- Aug 2013
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 5 Aug 2013 (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.
Medullary thyroid cancer is a neuroendocrine tumour. As so, it has somatostatin receptors in its membrane. Furthermore, very little is available to treat patients who have disease progression. The investigators hypothesized that those tumors may respond to 177-Lu-DOTA Tyr3-octreotate which is a ligand to somatostatin receptors.
Detailed description
Medullary thyroid carcinomas can also be located by scintigraphy with 111In-DTPA (diethylenetriamine pentaacetic acid) -octreotide. In some studies, there is a sensitivity for the detection of these tumors by this method, 50-70%. The relationship of calcitonin and carcinoembryonic antigen levels were significantly higher in patients in whom scintigraphy was performed with 111In-DTPA-octreotide. This implies that somatostatin receptors can be detected "in vivo" for different forms of medullary thyroid carcinoma Based on the specific binding of the analogs of somatostatin receptors present on the membrane of some tumors such as medullary thyroid been possible to devise a therapy to target-directed using both beta-emitting radionuclides (which have therapeutic properties) coupled to such molecules. The main radiopharmaceuticals used for this purpose are currently 177 Lu-DOTA-Tyr3-OCTREOTATE or 90Yttrium-DOTA]-TOC.
The medullary thyroid carcinoma (MTC) is a rare neuroendocrine tumor, accounting for only 4.9% of total thyroid carcinomas, however, compared to well differentiated carcinoma, presents a worse prognosis. The tumor staging, and restaging is essential since surgery is the only curative method. Elevated plasma concentrations of calcitonin (CT) and / or high levels of carcinoembryonic antigen (CEA), biochemical markers of MTC, suggest the presence of residual malignant disease / recurrence or metastasis at a distance. After surgery aggressive 40% of patients have persistent disease and about 10%, with undetectable post-surgery CT, develop tumor recurrence. At this point the therapeutic options are scarce and not available in our area. Although the investigators use the structural radiological study using ultrasound, computed tomography and magnetic resonance imaging for staging of the disease, they do not provide functional information. In this context, nuclear medicine examinations can add data such as growth potential and expression pattern of receptors for diagnostic and therapeutic purposes. In 2007, Ong SC. et al. Showed that 18 FDG PET / CT have the ability to detect residual disease, recurrent or metastatic disease with a sensitivity of 78% but only when calcitonin is up 1000pg/ml. Already Iten et al. Using the principle that these tumors express receptors for the somatostatin used OctreoScan ® and subsequent treatment with 90Yttrium-DOTA]-TOC showing not only an advantage for the location of the disease and the possibility of making an image guided therapy by. These authors also demonstrated a clinical benefit to the extent that 25% of the patients showed reduced calcitonin. The investigators hypothesized that those tumors may respond to 177-Lu-DOTA Tyr3-octreotate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lu 177 | Experimental | Radiation: Lu 177progressive metastatic medullary thyroid cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Medullary Thyroid Cancer
- Doubling time calcitonin and CEA less than 6 months
- Measurable disease by cross- sectional imaging
- Irresectable tumors masses
- > 18 years of age
Key exclusion criteria (3 listed)
- < 18 years of age
- Disease that can be treated with new surgical procedure
- Stable disease
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 |
|---|---|---|
| Lu 177Patients will be submitted to 4 cycles of 177-Lu with 200mCi each | Radiation | Lu 177 |
Primary outcome
Tumour Shrinkage
Time frame: 6-8 months
RECIST 1.1 criteria
1 secondary outcome
Quality of life improvement
Time frame: 6-8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
- Background: PubMed 18006770Iten F, Muller B, Schindler C, Rochlitz C, Oertli D, Macke HR, Muller-Brand J, Walter MA. Response to [90Yttrium-DOTA]-TOC treatment is associated with long-term survival benefit in metastasized medullary thyroid cancer: a phase II clinical trial. Clin Cancer Res. 2007 Nov 15;13(22 Pt 1):6696-702. doi: 10.1158/1078-0432.CCR-07-0935.
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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.
Fernanda Vaisman, MD, PhD principal investigator
National Cancer Institute, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lu 177 in people with Medullary Thyroid Cancer, run by Instituto Nacional de Cancer, Brazil at 1 site in Brazil.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernanda Vaisman, MD, PhD ((5521) 32071387, fevaisman@globo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumour Shrinkage (time frame: 6-8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01915485, which also lists 1 linked publication.
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 7 Sep 2016.