Clinical trial NCT02281149: Adjuvant Radiotherapy in Breast With Intensity Modulated by Tomotherapy:
Official title: Adjuvant Radiotherapy in Breast With Intensity Modulated by Tomotherapy: Evaluation of the Toxicity and Quality of Life
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Keywords: breast cancer
radiotherapy
intensity modulation
toxicity
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
First posted: 2014-11-02
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: prospective study of routine care done on women with breast cancer treated by adjuvant radiotherapy with intensity modulated

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.

Eligibility criteria: 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

Primary outcomes:
measure: acute and tardive toxicity according to NCI-CTCAE v4.0
timeFrame: up to 5 years
Secondary outcomes:
measure: Quality of life according to QLQC-30
timeFrame: up to 24 months
measure: Quality of life according to BR-23 module
timeFrame: up to 24 months
measure: Disease free survival
timeFrame: up to 5 years
measure: esthetic results
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Douai
country: France
facility: Centre Léonard de Vinci
city: Lille
country: France
facility: Centre Oscar Lambret
Study officials:
affiliation: Centre Oscar Lambret
name: David PASQUIER, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pasquier D, Bataille B, Le Tinier F, Bennadji R, Langin H, Escande A, Tresch E, Darloy F, Carlier D, Crop F, Lartigau E. Correlation between toxicity and dosimetric parameters for adjuvant intensity modulated radiation therapy of breast cancer: a prospective study. Sci Rep. 2021 Feb 11;11(1):3626. doi: 10.1038/s41598-021-83159-3.