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NCT03191643 Clinical Trial

PET-guided External Beam Radiotherapy in Differentiated Thyroid Cancer

Differentiated Thyroid Cancer Clinical Trial

Official title:
18F-FDG PET-guided External Beam Radiotherapy in Iodine-refractory Differentiated Thyroid Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03191643
Other study ID # Thyroid-COBRA
Secondary ID
Status Completed
Phase N/A
First received June 15, 2017
Last updated June 16, 2017
Start date October 1, 2011
Est. completion date January 31, 2016

Study information
Verified date June 2017
Source Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Description of the role of a post-operative external beam radiotherapy in patients with differentiated thyroid cancer.

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.

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date January 31, 2016
Est. primary completion date January 31, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- detectable thyroglobulin (Tg),

- negative post-metabolic radiotherapy whole body scintigraphy,

- no surgical indications.

Exclusion Criteria:

- prior radiotherapy in the head and neck area

- pregnancy

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Outcome
Type Measure Description Time frame Safety issue
Primary 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). 6 months
Secondary toxicities Acute and late toxicities after radiotherapy are assessed with CTCAE v. 4.03 and EORTC-RTOG scales, respectively. 6 months
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