Adjuvant Radiotherapy in Breast With Intensity Modulated by Tomotherapy:

NCT02281149 | Active Not Recruiting

• 2 other identifiers: TOMOBREAST-13072013-A01846-39
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Keywords

breast cancer; radiotherapy; intensity modulation; toxicity

Outcome Measures

Primary Outcomes (1)

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

  according to NCI-CTCAE v4.0

  up to 5 years

Secondary Outcomes (4)

• Quality of life according to QLQC-30

  up to 24 months

• Quality of life according to BR-23 module

  up to 24 months

• Disease free survival

  up to 5 years

• esthetic results

  up to 5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Centre Oscar Lambret: lead

Study Sites (2)

Centre Léonard de Vinci

Douai, 59500, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Related Publications (1)

• 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.

  PMID: 33574446 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• David PASQUIER, MD

  Centre Oscar Lambret

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2014
• First Posted: November 3, 2014
• Study Start: November 18, 2014
• Primary Completion: December 31, 2022
• Study Completion: March 31, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)