PET-guided External Beam Radiotherapy in Differentiated Thyroid Cancer

Completed

• Conditions: Differentiated Thyroid Cancer

• Registration Number: NCT03191643
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

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 Timeline

• Study Start: 2011-10-01
• Primary Completion: 2016-01-31
• Study Completion: 2016-01-31
• Status Verified: 2017-06
• Study First Submitted: 2017-06-15
• Study First Submitted QC: 2017-06-16
• Last Update Submitted: 2017-06-16
• Study First Posted: 2017-06-19
• Last Update Posted: 2017-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	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).

Secondary Outcome Measures

Name	Time	Method
toxicities	6 months	Acute and late toxicities after radiotherapy are assessed with CTCAE v. 4.03 and EORTC-RTOG scales, respectively.