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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05850637
Other study ID # INSTITUTO PREVENT SENIOR - IPS
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 30, 2019
Est. completion date April 1, 2023

Study information

Verified date April 2024
Source Prevent Senior Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Prospective phase 2 study to evaluate the safety and efficacy of ultra-hypofractionated adjuvant radiotherapy in 5 fractions of 5.7 Gy in patients aged over 65 years.


Description:

Prospective phase 2 non-randomized single-arm study to evaluate the safety and efficacy of ultra-hypofractionated adjuvant radiotherapy in 5 fractions of 5.7 Gy in patients aged over 65 years.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date April 1, 2023
Est. primary completion date February 11, 2021
Accepts healthy volunteers No
Gender Female
Age group 65 Years and older
Eligibility Inclusion Criteria: 1. Female patient; 2. Pathological confirmation of invasive breast carcinoma regardless of histological subtype and hormonal profile; 3. Age greater than or equal to 65 years; 4. Breast-conserving surgery or mastectomy with or without axillary approach 5. With or without neoadjuvant or adjuvant systemic treatment Exclusion Criteria: 1. Patients with previous thoracic irradiation; 2. Patients with indication for bilateral thoracic irradiation; 3. Patients with breast reconstruction with prosthesis or autologous tissue; 4. Patients with compromised surgical margins after resection; 5. pT1-pT2 pN0 patients undergoing radical mastectomy.

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
adjuvant ultra-hypofractionated radiotherapy
adjuvant ultra-hypofractionated radiotherapy for the treatment of early and locally advanced breast cancer

Locations

Country Name City State
Brazil Instituto de Pesquisa Prevent Senior São Paulo

Sponsors (1)

Lead Sponsor Collaborator
Prevent Senior Institute

Country where clinical trial is conducted

Brazil, 

References & Publications (79)

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* Note: There are 79 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Breast volume and toxicity relationship We analyzed the impact of CTV (Clinical Target Volume) volume (representing breast size), and dosimetric data, with a special focus on the maximum dose and dose in homogeneity (defined as the absolute volumes of breast tissue exposed to =100%, =104% and =107% of the prescribed dose 3 years
Primary Acute toxicity Acute skin toxicity was evaluated the criteria followed the Standard Common Terminology Criteria for Adverse Events - CTCAE v 5.0 Events of radiotherapy up to 3 months
Primary Late toxicity Delayed skin and subcutaneous toxicities were evaluated according to the Radiation Therapy Oncology Group (RTOG) classification. Events after 3 months of radiotherapy completion
Secondary Locoregional free survival from the date of initiation of treatment until the date of recurrence or progression of locoregional disease evidence 3 years
Secondary Distant free survival from the date of initiation of treatment until the date of progression of distant disease evidence 3 years
Secondary Overall survival defined from the date of initiation of treatment until the patient's death 3 years
Secondary Cosmesis change was assessed using the Harvard/NSABP/RTOG scale. The Harvard/NSABP/RTOG scale score is a 4-point breast cosmetic scale, which was assessed by clinicians at baseline (after surgery) and two additional times during follow-up.
Excellent: When compared to the untreated breast, there is no difference or minimal difference in the size or shape of the treated breast. The breast texture is the same or slightly different. There may be thickening, scar tissue, or fluid buildup in the breast, but not enough to change the appearance.
Good: There is a slight difference in the size or shape of the treated breast compared to the untreated breast or compared to the original appearance of the treated breast. There may be a slight reddening or darkening of the breast. Thickening or scar tissue inside the breast causes only a slight change in shape or size.
Fair: Obvious difference in the size and shape of the treated breast. This change involves a quarter or less of the breast. There may be
week 10 and week 26 after the end of the treatment
Secondary QOL (Quality of Life) changes was assessed using the scales proposed by the EORTC (European Organization for Research and Treatment of Cancer). The EORTC QOQ-C30 and EORTC QLQ-BR-23 scales.
All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
3 years
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