Clinical Trial of The Use of Bolus in Post Mastectomy Irradiation in Breast Cancer

NCT01925651 | Completed

• 1 other identifier: AC-B 01
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the impact of adding bolus in adjuvant radiotherapy after mastectomy, in relation to the time of treatment interruption and acute effects. This study evaluates whether there is an increase in treatment time with the addition of the bolus, which can overshadow the benefit of increased dose to the skin and subcutaneous tissue. The patients will continue to be followed for oncologic outcomes, focusing on chest wall local control.

Conditions

Breast Cancer; Radiodermatitis

Keywords

Post Mastectomy Radiotherapy; Breast Cancer; Bolus; Radiodermatitis

Outcome Measures

Primary Outcomes (1)

• Acute radiodermatitis

  Radiation Therapy Oncology Group (RTOG) grading system Common Terminology Criteria for Adverse Events (CTCAE) - v4.0

  participants will be followed for the duration of radiotherapy, an expected average of 6 weeks

Secondary Outcomes (1)

• Interruption Time

  participants will be followed for the duration of radiotherapy, an expected average of 6 weeks

Other Outcomes (4)

• Local Care Costs

  participants will be followed for the duration of radiotherapy, an expected average of 6 weeks

• Local Control

  From date of randomization until the date of first documented local progression in the chest wall or date of death from any cause, whichever came first, assessed up to 100 months

• Metastasis-Free Interval

  From date of randomization until the date of first documented distant progression or date of death from any cause, whichever came first, assessed up to 100 months

Study Arms (4)

Standard Risk - No bolus

OTHER

No Bolus

Radiation: No Bolus

Standard Risk - Alternate Bolus

OTHER

Alternate 5mm Bolus

Radiation: Alternate Bolus

High Risk - Alternate Bolus

OTHER

Alternate 5mm Bolus

Radiation: Alternate Bolus

High Risk - Continuous bolus

OTHER

Continuous 5mm bolus

Radiation: Continuous Bolus

Interventions

No Bolus RADIATION

no bolus use

Standard Risk - No bolus

Alternate Bolus RADIATION

0.5cm bolus use in alternate days

High Risk - Alternate Bolus; Standard Risk - Alternate Bolus

Continuous Bolus RADIATION

0.5 cm bolus use in continuous days

High Risk - Continuous bolus

Eligibility Criteria

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

You may qualify if:

• Undergoing mastectomy with or without reconstruction of early breast
• breast malignancy histologically proven

You may not qualify if:

• Karnofsky Performance Scale (KPS) \<70%
• Concomitant chemotherapy (only permitted or hormone therapy molecular-targeted)
• Prior ipsilateral thoracic / cervical irradiation
• Proven metastatic disease (excluded from oncologic outcomes analyses)

Sponsors & Collaborators

• AC Camargo Cancer Center: lead

Study Sites (1)

AC Camargo Cancer Center

São Paulo, São Paulo, 01509-010, Brazil

Location

MeSH Terms

Conditions

Breast Neoplasms; Radiodermatitis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Dermatitis; Radiation Injuries; Wounds and Injuries

Study Officials

• Lucas G Sapienza, MD, PhD

  AC Camargo Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: August 15, 2013
• First Posted: August 20, 2013
• Study Start: August 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: November 1, 2021
• Last Updated: July 20, 2022

Record last verified: 2022-07

Locations

BR (1)