Evaluate the Effectiveness and Toxicity of Adjuvant Ultra-hypofractionated Radiotherapy for Breast Cancer

Breast Cancer Female Clinical Trial

Official title:

Phase II Study to Evaluate the Effectiveness and Toxicity of Adjuvant Ultra-hypofractionated Radiotherapy for the Treatment of Early and Locally Advanced Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05850637
• Other study ID #: INSTITUTO PREVENT SENIOR - IPS
• Status: Completed
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

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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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