Radiotherapy in thyroid carcinoma

ISRCTN	ISRCTN27923044
DOI	https://doi.org/10.1186/ISRCTN27923044
Secondary identifying numbers	OI-RTX-DTC

Submission date: 04/01/2018
Registration date: 12/01/2018
Last edited: 12/01/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Prof Nikola Besic
Scientific

Institute of Oncology
Zaloska 2
Ljubljana
1000
Slovenia

ORCID ID	0000-0002-9874-8767
Phone	+286 15879518
Email	nbesic@onko-i.si

Study information

Study design	Retrospective single-centre observational study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	No participant information sheet available
Scientific title	Locoregional Disease Control after External Beam Radiotherapy in Patients with Differentiated Thyroid Carcinoma and pT4 Tumor Stage
Study acronym	LC EBRT DTC
Study objectives	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(s)	Protocol Review Board Ethics Committee of the Institute of Oncology, 18/11/2010, ref: KSOPKR/18/11/10
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	20/06/2010
Completion date	04/01/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	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.
Key inclusion criteria	1. Differentiated thyroid carcinoma -pT4 tumor stage 2. Males or females older than 18 years of age
Key exclusion criteria	Younger than 18 years of age.
Date of first enrolment	01/01/2013
Date of final enrolment	13/12/2015

Locations

Countries of recruitment

Slovenia

Study participating centre

Institute of Oncology Ljubljana

Ljubljana
1000
Slovenia

Sponsor information

Institute of Oncology
Hospital/treatment centre

Institute of Oncology
Zaloska 2
Ljubkjana
1000
Slovenia

Phone	+386 158 79518
Email	nbesic@onko-i.si
"ROR"	https://ror.org/00y5zsg21

Funders

Funder type

Government

Slovenian Research Agency (AARS)

No information available

Results and Publications

Intention to publish date	04/01/2018
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	Planned publication in BMC Cancer.
IPD sharing plan	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.