Adjuvant Radiotherapy in Breast With Intensity Modulated by Tomotherapy:

Active, not recruiting

• Conditions: Breast Cancer

• Registration Number: NCT02281149
• Lead Sponsor: Centre Oscar Lambret

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2014-10-28
• Study First Submitted QC: 2014-10-31
• Study First Posted: 2014-11-02
• Study Start: 2014-11-18
• Primary Completion: 2022-12-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-04
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
acute and tardive toxicity according to NCI-CTCAE v4.0	up to 5 years	according to NCI-CTCAE v4.0

Secondary Outcome Measures

Name	Time	Method
Disease free survival	up to 5 years	according to RECIST 1.1
Quality of life according to QLQC-30	up to 24 months	Quality of life according to QLQC-30
Quality of life according to BR-23 module	up to 24 months	Quality of life according to BR-23 module
esthetic results	up to 5 years	by physician and patient according to a scale (good, excellent, moderate and poor)

Trial Locations

Locations (2)

Centre Léonard de Vinci; 🇫🇷 Douai, France

Centre Oscar Lambret; 🇫🇷 Lille, France