Adjuvant Radiotherapy in Breast With Intensity Modulated by Tomotherapy:

Breast Cancer Clinical Trial

— TOMOBREAST  

Official title:

Adjuvant Radiotherapy in Breast With Intensity Modulated by Tomotherapy: Evaluation of the Toxicity and Quality of Life

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02281149
• Other study ID #: TOMOBREAST-1307
• Status: Active, not recruiting
• Start date: November 18, 2014
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Adjuvant radiotherapy after lumpectomy allows a local long-term control of the order 85 to 95% with a survival rate equivalent to that of the totally mastectomy. The diminution of the local recurrence rate after irradiation post- lumpectomy is also associated to a best global survival than only the surgery. The adjuvant radiotherapy after partially or totally mastectomy for the progressive tumors is a therapeutic standard (Early Breast Cancer Trialists' Collaborative Group 2011). The aim of our trial of routine care is to record our practices under this breast adjuvant radiotherapy.

Description:

Patients responding criteria for selection and not objecting to participate in this trial will address the quality of life questionnaires at baseline and during their standard follow-up (1, 6, 12 and 24 months after the end of radiotherapy). The data of toxicity and disease-free survival will be collected from data on medical record of the patient.

The therapeutic support and monitoring are standard.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1-Patient with breast cancer proved by histology and treated surgically 2. Relevant of adjuvant radiotherapy after partial or total mastectomy with or without lymph node irradiation 3- Age = 18 years 4- Information and no opposition to the patient

Exclusion Criteria:

1. - Metastatic disease

2. - Patient having another severe disease or uncontrolled which could jeopardize the trial participation

3. - pregnant or breastfeeding woman 4-inability to do follow-up medical care of clinical trial for geographical, social or psychological reasons

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
France	Centre Léonard de Vinci	Douai
France	Centre Oscar Lambret	Lille

Sponsors (1)

Lead Sponsor	Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	acute and tardive toxicity according to NCI-CTCAE v4.0	according to NCI-CTCAE v4.0	up to 5 years
Secondary	Quality of life according to QLQC-30	Quality of life according to QLQC-30	up to 24 months
Secondary	Quality of life according to BR-23 module	Quality of life according to BR-23 module	up to 24 months
Secondary	Disease free survival	according to RECIST 1.1	up to 5 years
Secondary	esthetic results	by physician and patient according to a scale (good, excellent, moderate and poor)	up to 5 years