NCT03191643

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2011

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 19, 2017

Completed
Last Updated

June 19, 2017

Status Verified

June 1, 2017

Enrollment Period

4.3 years

First QC Date

June 15, 2017

Last Update Submit

June 16, 2017

Conditions

Differentiated Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • toxicities

    6 months

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • detectable thyroglobulin (Tg),
  • negative post-metabolic radiotherapy whole body scintigraphy,
  • no surgical indications.

You may not qualify if:

  • prior radiotherapy in the head and neck area
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 29201490DERIVED

Study Officials

  • Alessio G. Morganti, MD

    Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S.Orsola-Malpighi Hospital, Bologna, Italy

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 15, 2017

First Posted

June 19, 2017

Study Start

October 1, 2011

Primary Completion

January 31, 2016

Study Completion

January 31, 2016

Last Updated

June 19, 2017

Record last verified: 2017-06