PET-guided External Beam Radiotherapy in Differentiated Thyroid Cancer

June 16, 2017 updated by: Alessio Giuseppe Morganti, IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

16

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
toxicities
Time Frame: 6 months
Acute and late toxicities after radiotherapy are assessed with CTCAE v. 4.03 and EORTC-RTOG scales, respectively.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

  • Study Director: Alessio G. Morganti, MD, Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S.Orsola-Malpighi Hospital, Bologna, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2011

Primary Completion (ACTUAL)

January 31, 2016

Study Completion (ACTUAL)

January 31, 2016

Study Registration Dates

First Submitted

June 15, 2017

First Submitted That Met QC Criteria

June 16, 2017

First Posted (ACTUAL)

June 19, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 19, 2017

Last Update Submitted That Met QC Criteria

June 16, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Thyroid-COBRA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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