NCT02824016

Brief Summary

Prospective, multicentric, comparative, non randomised, in current care. Primary objective:

  • To evaluate the incidence of hypothyroidism in breast cancer patients treated by radiotherapy including the supra-clavicular area over a period of 5 years (60 months). Secondary objectives :
  • To calculate the dose of irradiation received by thyroid gland during the treatment.
  • To compare the rate of incidence of hypothyroidism in women who received a supra-clavicular irradiation (group 1)and in those who did not (group 2).
  • To estimate and compare the rate of incidence of chronic thyroid lesions in the 2 groups.
  • To look for predictive factors of hypothyroidism de novo in group 1 women particularly regarding the dose-volume parameters.
  • To propose recommendations for the thyroid follow-up after supra-clavicular irradiation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

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

February 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1 year until next milestone

First Posted

Study publicly available on registry

July 6, 2016

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

August 31, 2021

Status Verified

August 1, 2021

Enrollment Period

2.4 years

First QC Date

August 25, 2014

Last Update Submit

August 30, 2021

Conditions

Irradiation; Adverse EffectIrradiation Hypothyroidism

Outcome Measures

Primary Outcomes (1)

  • Number of patients with treatment-related adverse effects on thyroid function as assessed by CTCAE v4.0

    Outcome measures will be assessed every 6 months up to 5 years.

Study Arms (2)

with supraclavicular irradiation

ACTIVE COMPARATOR

Patients received supraclavicular irradiation according to local policies. Biological samples were obtained in order to evaluate hypothyroidism during the follow-up period

Biological: biological sampleRadiation: supraclavicular irradiation

without supraclavicular irradiation

ACTIVE COMPARATOR

Patients did not receive supraclavicular irradiation according to local policies. Biological samples were obtained in order to evaluate hypothyroidism during the follow-up period

Biological: biological sample

Interventions

biological sampleBIOLOGICAL

T4, thyrotropic-stimulating hormone (TSH) and Thyroglobulin antibody were systematically measured

with supraclavicular irradiationwithout supraclavicular irradiation
supraclavicular irradiationRADIATION

Irradiation of the homolateral supraclavicular area delivering 46 Gy in 23 fractions

with supraclavicular irradiation

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women older than 18
  • Non metastatic breast cancer, histologically proved, whatever T and N stages and receptors status.
  • Breast cancer treated by surgery (either initial treatment then biotherapies and/or neoadjuvant chemotherapy, either secondarily after biotherapies and/or neoadjuvant chemotherapy, either without chemotherapy and/or biotherapies)
  • Breast cancer requiring an adjuvant radiotherapy
  • Treatment by radiotherapy made in participating centers
  • Information of patient and signature of the informed consent.

You may not qualify if:

  • History of thyroid surgery
  • Bilateral breast cancer
  • History of cervical and/or supra-clavicular radiotherapy
  • Lack of social security insurance
  • Subjects deprived of free behavior or under administrative control

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Institut Jean Godinot

Reims, 51100, France

Location

Centre Paul Strauss

Strasbourg, 67000, France

Location

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Location

Study Officials

  • Yacine MERROUCHE, MD

    Institut Jean-Godinot

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 25, 2014

First Posted

July 6, 2016

Study Start

February 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2020

Last Updated

August 31, 2021

Record last verified: 2021-08

Locations

FR(3)