Toxicity and Outcome of Whole Breast Hypofractionated Radiotherapy: a Single Institution Experience

NCT03077191 | Active Not Recruiting

• 1 other identifier: Ipomammella
• Study Type: observational
• Target: 410
• Locations: 1 country
• Sites: 1

Brief Summary

This is a homogeneous, single institution, observational, non-interventional, prospective study of 500 patients who will be treated according to the standard protocol of adjuvant hypofractionated radiotherapy after breast conserving surgery, at a total dose of 40 Gy/ 15 fr (5 fr/ week, 3 consecutive weeks). In addition to the regular follow up, the patients will respond to the quality-of-life questionnaires (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC), general, QLQ- C30, and specific for breast (BR), QLQ- BR23, at the first visit, at the end of radiotherapy and at the subsequent follow-up visits from 6 months up to 5 and a half years, to evaluate the quality of life during and after the treatment. The study also has a retrospective arm of approximately 3300 patients (number of patients and characteristics of disease expanded with the amendment presented to the Lombardia 1 Ethics Committee in May 22/2024), treated from January 2009, for whom disease control and toxicity will be evaluated.

Conditions

Breast Cancer; Quality of Life; Radiotherapy; Adverse Effect, Dermatitis or Eczema; Survivorship

Keywords

hypofractionated whole breast radiotherapy; breast cancer; conservative treatment; quality of life

Outcome Measures

Primary Outcomes (2)

• quality of life after hypofractionated adjuvant radiotherapy

  degree of general quality of life worsening of patients treated with hypofractionated adjuvant radiotherapy after breast conserving surgery assessed with EORTC quality of life questionnaires QLQ C30

  up to 66 months

• breast specific quality of life after hypofractionated adjuvant radiotherapy

  degree of specific quality of life worsening of patients treated with hypofractionated adjuvant radiotherapy after breast conserving surgery assessed with EORTC quality of life questionnaire QLQ BR23

  up to 66 months

Secondary Outcomes (9)

• Local Relapse Free Survival

  From the date of radiotherapy end until the date of local progression or date of death from any cause, whichever came first, assessed up to 120 months

• Regional Relapse Free Survival

  From the date of radiotherapy end until the date of regional progression or date of death from any cause, whichever came first, assessed up to 120 months

• Distant Metastases Free Survival

  From the date of radiotherapy end until the date of distant progression or date of death from any cause, whichever came first, assessed up to 120 months

• Disease Free Survival

  From the date of radiotherapy end until the date of first documented clinical progression or date of death from any cause, whichever came first, assessed up to 120 months

• Cancer Specific Survival

  From the date of radiotherapy end until the date of death from disease progression, assessed up to 120 months

Other Outcomes (5)

• Aesthetic result

  From three months after the start of radiotherapy until the end of follow-up or death, assessed up to 120 months

• Predictive factor for disease progression and death

  From radiotherapy end to date of local, regional progression, distant failure, or death, assessed up to 120 months

• Radiomic predictive factors for disease progression and death

  From radiotherapy end to the first registered event (disease progression or death), assessed up to 120 months

Study Arms (2)

Quality of life

Quality of life of breast cancer patients treated with conservative surgery (quadrantectomy) and adjuvant hypofractionated whole breast radiotherapy according to the institutional standard regimen, to a total dose of 40 Gy in 15 fraction over 3 weeks will be measured with EORTC quality of life questionnaires QLQ-C30 and QLQ-BR23, before the start of the radiotherapy, at the end of the radiotherapy and subsequently at every follow-up visit (the first at 6 months after the end of the treatment, then annually for 5 consecutive years after the first follow up visit).

Other: Quality of life measurement

Breast cancer, retrospective

In the observational retrospective cohort patients with histologically confirmed breast cancer treated with hypofractionated/ultrahypofractionated radiotherapy to: * whole breast +/- Simultaneous Integrated Boost (SIB) to surgical bed, * breast/chest wall and lymph node areas +/- SIB to surgical bed, * surgical bed only, with accelerated partial breast irradiation, using 3D conformal radiotherapy or advanced radiotherapy techniques (IGRT, IMRT, SBRT) will be included.

Interventions

Quality of life measurement OTHER

The quality of life of breast cancer patients treated with conservative surgery and adjuvant whole breast hypofractionated radiotherapy, without boost, will be evaluated.

Quality of life

Eligibility Criteria

• Age: 18 Years - 85 Years
• Gender Eligibility Details: Women with breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients treated with surgery (conservative/mastectomy), and hypofractionated/ultrahypofractionated radiotherapy to surgical bed or whole breast +/-SIB, +/- regional lymph nodes

You may qualify if:

• Breast cancer patients with TNM Classification of Malignant Tumours pathological stage Tis-T4d, N0-N3, treated with surgery (conservative or mastectomy), accelerated partial breast irradiation or whole breast hypofractionated radiotherapy +/-SIB +/- regional lymph node irradiation

You may not qualify if:

• \- male breast cancer patients

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS San Raffaele Scientific Institute

Milan, MI, 20132, Italy

Location

Related Publications (37)

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MeSH Terms

Conditions

Breast Neoplasms; Dermatitis; Eczema

Condition Hierarchy (Ancestors)

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

Study Officials

• Andrei Fodor, M.D.

  IRCCS San Raffaele Scientific Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: March 10, 2017
• Study Start: November 1, 2016
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: for 2 years after the study closes
• Access Criteria: Request from the corresponding author approved by the Lombardy Territorial Ethics Committee 1

Locations

IT (1)