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Completed

NCT Number: NCT02281149

Adjuvant Radiotherapy in Breast With Intensity Modulated by Tomotherapy:

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Centre Léonard de Vinci, Douai, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • - Metastatic disease
  • - Patient having another severe disease or uncontrolled which could jeopardize the trial participation
  • - pregnant or breastfeeding woman 4-inability to do follow-up medical care of clinical trial for geographical, social or psychological reasons

Treatment and study plan

Primary outcomes

  1. acute and tardive toxicity according to NCI-CTCAE v4.0

    Time frame: up to 5 years

    according to NCI-CTCAE v4.0

Secondary outcomes

  1. Quality of life according to QLQC-30

    Time frame: up to 24 months

    Quality of life according to QLQC-30

  2. Quality of life according to BR-23 module

    Time frame: up to 24 months

    Quality of life according to BR-23 module

  3. Disease free survival

    Time frame: up to 5 years

    according to RECIST 1.1

  4. esthetic results

    Time frame: up to 5 years

    by physician and patient according to a scale (good, excellent, moderate and poor)

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Registry information

Official study title

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

Acronym: TOMOBREAST

Important dates

Study start
2014
Primary completion
2022
Study completion
2026
First posted
Nov 3, 2014
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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