Adjuvant Radiotherapy in Breast With Intensity Modulated by Tomotherapy:

NCT ID: NCT02281149

Last Updated: 2024-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-18

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Oscar Lambret

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David PASQUIER, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Oscar Lambret

Locations

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Centre Léonard de Vinci

Douai, , France

Site Status

Centre Oscar Lambret

Lille, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 33574446 (View on PubMed)

Other Identifiers

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TOMOBREAST-1307

Identifier Type: -

Identifier Source: org_study_id

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