Condition category
Cancer
Date applied
04/01/2018
Date assigned
12/01/2018
Last edited
12/01/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Differentiated thyroid carcinoma (DTC) (also known as thyroid cancer) is commonly known to recur in patients with advance cases. The aim of this study is to find out how effective is external beam radiotherapy of the neck region in patients with locally advanced thyroid carcinoma for prevention of locoregional recurrence of disease.

Who can participate?
Adults aged 18 and older who were treated with radiotherapy for thyroid carcinoma.

What does the study involve?
Participants with DTC who had external beam radiotherapy of the neck and mediastinum as part of multimodal treatment of locally advanced tumor from year 1973 to 2015 have their medical notes reviewed for information about the control rate and survival.

What are the possible benefits and risks of participating?
There are no benefits or risks with participating in this study.

Where is the study run from?
Institute of Oncology Ljubljana (Slovenia)

When is the study starting and how long is it expected to run for?
June 2010 to January 2018

Who is funding the study?
Slovenian Research Agency (AARS) (Slovenia)

Who is the main contact?
Professor Nikola Besic (Scientific)
nbesic@onko-i.si

Trial website

Contact information

Type

Scientific

Primary contact

Prof Nikola Besic

ORCID ID

http://orcid.org/0000-0002-9874-8767

Contact details

Institute of Oncology
Zaloska 2
Ljubljana
1000
Slovenia
+286 15879518
nbesic@onko-i.si

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

OI-RTX-DTC

Study information

Scientific title

Locoregional Disease Control after External Beam Radiotherapy in Patients with Differentiated Thyroid Carcinoma and pT4 Tumor Stage

Acronym

LC EBRT DTC

Study hypothesis

Our aim was to find out the rate of locoregional control of the disease after external beam radiotherapy (EBRT) of the neck and mediastinum in patients with DTC and pT4 tumor.

Ethics approval

Protocol Review Board Ethics Committee of the Institute of Oncology, 18/11/2010, ref: KSOPKR/18/11/10

Study design

Retrospective single-centre observational study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Differentiated thyroid carcinoma - pT4 tumor stage

Intervention

All 91 patients included in this report had EBRT to the neck and superior mediastinum. Six patients were treated preoperatively with EBRT, four of them with concomitant chemotherapy and two with EBRT only. Even 63 (69%) of our patents were irradiated using antero-posterior opposed fields in supine position with extended neck. The target volume extended from mastoid tips cranially to tracheal bifurcation caudally and to the coracoids laterally, to cover neck lymph nodes regions I-VI, thyroid bed and superior mediastinal lymph nodes. The two beams, using Cobalt unit or 6 MV photon beams, were weighted anteriorily; dose from the anterior field was 1.2 Gray (Gy) and from posterior field 0.6 Gy per fraction, 5 fractions per week. The apices of the lungs were shielded; after the received dose of 39.6 Gy. The spinal cord was also shielded from the posterior field, so the dose to the spinal cord was kept bellow 45 Gy. The prescribed dose to the midplane in vast majority of postoperative patients was 50.4 Gy. A boost dose of 6 - 16 Gy with 1.8 - 2 Gy per fraction was delivered to some patients with macroscopic remnant of disease using photon beams or electron beams avoiding spinal cord. Eight patients were irradiated by 3D technique (TD 50.4-70 Gy, median 63.5 Gy) and 20 patients by intensity-modulated radiotherapy (IMRT) technique (TD 56-70 Gy, median 64 Gy) to the whole neck and mediastinum, while only one patient had only thyroid bed irradiation. The five of six patients treated with EBRT before surgery received 36 Gy before surgery and 14 Gy after surgery, while one patient treated with EBRT before surgery received 50 Gy with IMRT technique.

Patients medical notes are reviewed to take information about locoregional recurrence, cause specific survival and overall survival.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Locoregional control rate was calculated by reviewing patient charts at five and ten years after external beam radiotherapy.

Secondary outcome measures

1. Cause-specific survival was calculated using survival curves from patient charts at five and ten years after initial therapy
2. Overall survival was calculated using survival curves from patient charts at five and ten years after initial therapy

Overall trial start date

20/06/2010

Overall trial end date

04/01/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Differentiated thyroid carcinoma -pT4 tumor stage
2. Males or females older than 18 years of age

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

All 91 patients treated with external beam irradiation at the Institute of Oncology Ljubljana from the year 1973 to 2015.

Participant exclusion criteria

Younger than 18 years of age.

Recruitment start date

01/01/2013

Recruitment end date

13/12/2015

Locations

Countries of recruitment

Slovenia

Trial participating centre

Institute of Oncology Ljubljana
Ljubljana
1000
Slovenia

Sponsor information

Organisation

Institute of Oncology

Sponsor details

Institute of Oncology
Zaloska 2
Ljubkjana
1000
Slovenia
+386 158 79518
nbesic@onko-i.si

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Slovenian Research Agency (AARS)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in BMC Cancer.

IPD sharing statement:
We will not provide a dataset because it is in Slovenian language. The dataset will be held in archives of the Research Department of the Institute of Oncology Ljubljana.

Intention to publish date

04/01/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes