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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2021-06-30

Brief Summary

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

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Detailed Description

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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).

Conditions

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Radiotherapy Side Effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Sequential boost

Intervention Type RADIATION

Boost (10 Gy/4 fx/1 week) is given after whole breast irradiation

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

Group Type EXPERIMENTAL

Concomitant boost

Intervention Type RADIATION

Boost (8 Gy/15 fx/3 weeks) is given with whole breast irradiation

Interventions

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Sequential boost

Boost (10 Gy/4 fx/1 week) is given after whole breast irradiation

Intervention Type RADIATION

Concomitant boost

Boost (8 Gy/15 fx/3 weeks) is given with whole breast irradiation

Intervention Type RADIATION

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No