Differentiated Thyroid CancerNCT03191643
PET-guided External Beam Radiotherapy in Differentiated Thyroid Cancer
An observational study of Differentiated Thyroid Cancer, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna.
Trial summary
Description of the role of a post-operative external beam radiotherapy in patients with differentiated thyroid cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Differentiated Thyroid Cancer
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2011to 31 Jan 2016
- Phase
- Observational
- 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
Study population: Patients with locally recurrent thyroid cancer, treated with radical external beam radiotherapy (EBRT) after total thyroidectomy +/- central compartment and/or laterocervical lymphadenectomy, previously treated with one or more cycles of 131 Iodine-ablation (RAI) and TSH suppression.
Who may be able to join
- detectable thyroglobulin (Tg),
- negative post-metabolic radiotherapy whole body scintigraphy,
- no surgical indications.
Who cannot join
- prior radiotherapy in the head and neck area
- pregnancy
About this study
Official title: 18F-FDG PET-guided External Beam Radiotherapy in Iodine-refractory Differentiated Thyroid Cancer
Description of the role of a post-operative external beam radiotherapy in patients with differentiated thyroid cancer.
Read the detailed description
The role of post-operative external beam radiotherapy (EBRT) in differentiated thyroid cancer is still discussed considering the low clinical aggressiveness and the availability of ablative 131Iodine therapy. However, there is a subgroup of tumors which lose the ability to capture Iodine over time. This study wants to describe the role of a post-operative external beam radiotherapy in patients with differentiated thyroid cancer.
- Conditions
- Differentiated Thyroid Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| differentiated thyroid cancer | Patients with locally recurrent thyroid cancer, treated with radical radiotherapy after total thyroidectomy +/- central compartment and/or laterocervical lymphadenectomy, previously treated with one or more cycles of 131 Iodine-ablation (RAI) and TSH suppression. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Progression-free survival (PFS) after radiotherapy is evaluated with CT-scan and 18F FDG PET-scan. Also laboratory tests are performed (HTG serum level evaluation in case of biochemical recurrence).
Measured: 6 months
Secondary outcomes (1)
toxicities
Acute and late toxicities after radiotherapy are assessed with CTCAE v. 4.03 and EORTC-RTOG scales, respectively.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start1 Oct 2011
- Primary completion31 Jan 2016
- Study completion31 Jan 2016
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 Differentiated Thyroid CancerStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessio Giuseppe Morganti, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- Alessio G. Morganti, MD, Study director, Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S.Orsola-Malpighi Hospital, Bologna, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191643
- Sponsor's protocol ID
- Thyroid-COBRA
- Status last verified
- Jun 2017
- First submitted
- 15 Jun 2017
- Last updated
- 19 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Farina E, Monari F, Castellucci P, Romani F, Repaci A, Farina A, Zanirato Rambaldi G, Frezza G, Mazzarotto R, Cammelli S, Tagliaferri L, Autorino R, Deodato F, Macchia G, Cilla S, Valentini V, Fanti S, Morganti AG. 18F-FDG Pet-Guided External Beam Radiotherapy in Iodine-Refractory Differentiated Thyroid Cancer: A Pilot Study. J Thyroid Res. 2017;2017:9807543. doi: 10.1155/2017/9807543. Epub 2017 Oct 19.
PubMed 29201490
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-FDG PET-guided External Beam Radiotherapy in Iodine-refractory Differentiated Thyroid Cancer
- ClinicalTrials.gov ID
- NCT03191643
- Acronym / sponsor ID
- Thyroid-COBRA
- Conditions
- Differentiated Thyroid Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Oct 2011 (actual)
- Primary completion
- 31 Jan 2016 (actual)
- Study completion
- 31 Jan 2016 (actual)
- First posted
- 19 Jun 2017 (actual)
- 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.
Description of the role of a post-operative external beam radiotherapy in patients with differentiated thyroid cancer.
Detailed description
The role of post-operative external beam radiotherapy (EBRT) in differentiated thyroid cancer is still discussed considering the low clinical aggressiveness and the availability of ablative 131Iodine therapy. However, there is a subgroup of tumors which lose the ability to capture Iodine over time. This study wants to describe the role of a post-operative external beam radiotherapy in patients with differentiated thyroid cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| differentiated thyroid cancer | – | –Patients with locally recurrent thyroid cancer, treated with radical radiotherapy after total thyroidectomy +/- central compartment and/or laterocervical lymphadenectomy, previously treated with one or more cycles of 131 Iodine-ablation (RAI) and TSH suppression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with locally recurrent thyroid cancer, treated with radical external beam radiotherapy (EBRT) after total thyroidectomy +/- central compartment and/or laterocervical lymphadenectomy, previously treated with one or more cycles of 131 Iodine-ablation (RAI) and TSH suppression.
Key inclusion criteria (3 listed)
- detectable thyroglobulin (Tg),
- negative post-metabolic radiotherapy whole body scintigraphy,
- no surgical indications.
Key exclusion criteria (2 listed)
- prior radiotherapy in the head and neck area
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression free survival (PFS)
Time frame: 6 months
Progression-free survival (PFS) after radiotherapy is evaluated with CT-scan and 18F FDG PET-scan. Also laboratory tests are performed (HTG serum level evaluation in case of biochemical recurrence).
1 secondary outcome
toxicities
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2017.
- Derived from this study: PubMed 29201490Farina E, Monari F, Castellucci P, Romani F, Repaci A, Farina A, Zanirato Rambaldi G, Frezza G, Mazzarotto R, Cammelli S, Tagliaferri L, Autorino R, Deodato F, Macchia G, Cilla S, Valentini V, Fanti S, Morganti AG. 18F-FDG Pet-Guided External Beam Radiotherapy in Iodine-Refractory Differentiated Thyroid Cancer: A Pilot Study. J Thyroid Res. 2017;2017:9807543. doi: 10.1155/2017/9807543. Epub 2017 Oct 19.
- Individual participant dataSharing planned: Undecided
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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.
Alessio G. Morganti, MD study director
Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S.Orsola-Malpighi Hospital, Bologna, Italy
Questions about this trial
What is this clinical trial studying?
An observational study of Differentiated Thyroid Cancer, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna.
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 3 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: finished, as of the sponsor's last update on 19 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Progression free survival (PFS) (time frame: 6 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 NCT03191643, 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 19 Jun 2017.