Accelerated Hypofractionated Whole Breast Irradiation Plus Sequential Boost Versus Concomitant Boost Following BCS

Not Applicable

• Conditions: Radiotherapy Side Effect
• Interventions: Radiation: Concomitant boost; Radiation: Sequential boost

• Registration Number: NCT03710733
• Lead Sponsor: National Cancer Institute, Egypt

Brief Summary

A prospective study comparing sequential versus concomitant radiotherapy boost in breast conservative therapy.

Detailed Description

This study is a prospective randomized non-inferiority trial of accelerated hypofractionated whole breast irradiation plus sequential boost versus concomitant boost after breast conservative surgery. It will be conducted on 124 patients who will be randomized using permuted blocks. The primary outcome measured is the cosmetic outcome, while secondary outcomes are patient satisfaction (using breast questionnaire), acute toxicity (using RTOG acute toxicity scoring criteria), and late toxicity (using RTOG late toxicity scoring criteria).

Study Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2018-07-07
• Study First Submitted QC: 2018-10-16
• Study First Posted: 2018-10-18
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-09
• Last Update Posted: 2020-09-11
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 185

Inclusion Criteria

• Histopathologically proven breast cancer resected by lumpectomy

• Female patient

• Invasive breast cancer

• Negative surgical margin

• Age < or equal 50 years, or high-grade irrespective of age

• Appropriate stage for protocol entry i.e. no metastasis

• Performance Status 0-2

• Hormone receptor status:

  1. ER/PR Known
  2. Borderline results are considered positive

Exclusion Criteria

• Metastatic patients
• Paget's disease of nipple
• Non-epithelial breast malignancy e.g. sarcoma, lymphoma
• Unresected suspicious microcalcifications in the same or contralateral breast
• Pregnant women
• Inability to delineate lumpectomy cavity
• Psychiatric or addictive disorders rendering treatment or follow-up difficult

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Concomitant boost	Concomitant boost	Hypofractionated whole breast irradiation 40 Gy/15 fx (2.67 Gy/fx) plus concomitant boost 8 Gy/15 fx (0.53 Gy/fx) to lumpectomy cavity
Sequential boost	Sequential boost	Hypofractionated whole breast irradiation 40 Gy/15 fx (2.67 Gy/fx) plus sequential boost 10 Gy/4 fx (2.5 Gy/fx) to lumpectomy cavity

Primary Outcome Measures

Name	Time	Method
Change in Breast Cosmetic Outcome	1 year	Rate the qualities of the treated breast as compared with the untreated breast using European Organization for Research and Treatment of Cancer (EORTC) Cosmetic Rating System

Secondary Outcome Measures

Name	Time	Method
Acute Toxicity (Breast Skin)	During treatment and up to 3 months after treatment	Using Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria
Late Toxicity (Breast Skin, Heart, Lungs)	1 year	Using Radiation Therapy Oncology Group (RTOG) Late Radiation Morbidity Scoring Criteria
Patient Satisfaction: Breast Questionnaire (Breast Q)	1 year	Using Breast Questionnaire (Breast Q)

Trial Locations

Locations (1)

National Cancer Institute, Egypt; 🇪🇬 Cairo, Egypt