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

National Cancer Institute, Egypt

Status: Unknown

Conditions: Radiotherapy Side Effect

Treatments: Radiation: Sequential boost; Radiation: Concomitant boost

Study type: Interventional

Funder types: Other

Identifiers

NCT03710733

201617079.3

Details and patient eligibility

About

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

Full 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).

Enrollment: 185 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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185 participants in 2 patient groups

Sequential boost

Active Comparator group

Description:

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

Treatment:

Radiation: Sequential boost

Concomitant boost

Experimental group

Description:

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

Treatment:

Radiation: Concomitant boost