MedTrace Logo

Comparison of Acute Toxicity and Cost Between Whole Breast Irradiation With Sequential Boost and Simultaneous Integrated Boost After Breast Conserving Surgery.

NCT01973634 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2022-12-02

No results posted yet for this study

Summary

Whole breast irradiation (WBI) after breast conserving surgery for early-stage breast cancer halves the recurrence risk and reduces the breast cancer death by about one sixth. A sequential boost (SeqB) dose to the tumour bed further improves local control, but also increases the risk of late skin toxicity and cosmetic changes. At Ghent University Hospital WBI is prescribed in 15 fractions of 2.67 Gy according to the START-B hypofractionation scheme. A sequential boost is typically given in 4 to 8 extra fractions which prolongs the overall treatment time. The boost dose can also be delivered within the 15 fractions of WBI, the so-called simultaneous integrated boost (SIB). SIB shortens the overall treatment time which is convenient for the patient and the radiotherapy department. In this study we wish to test the hypothesis of acceptable skin toxicity and reduced cost with SIB using hypofractionated prone intensity modulation radiotherapy IMRT with topographical dose painting, a technique recently developed in our group. Patients are randomized between SeqB and SIB.

Conditions

  • Radiotherapy After Breast Conserving Surgery

Interventions

RADIATION

sequential boost (15 x 2.67 Gy WBI + 4 x 2.5 Gy boost)

Minimal surgical margin of 1 mm, conventional arm with sequential boost (15 x 2.67 Gy WBI + 4 x 2.5 Gy boost)

RADIATION

SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.12 Gy)

Minimal surgical margin of 1 mm, experimental arm with SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.12 Gy)

RADIATION

sequential boost (15 x 2.67 Gy WBI + 6 x 2.48 Gy boost)

Minimal surgical margin \< 1 mm, conventional arm with sequential boost (15 x 2.67 Gy WBI + 6 x 2.48 Gy boost)

RADIATION

SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.33 Gy)

Minimal surgical margin \< 1 mm, experimental arm with SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.33 Gy)

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Wilfried De Neve, MD, PhD · University Hospital, Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2015-12-31
Completion
2021-03-31

Countries

  • Belgium

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01973634 on ClinicalTrials.gov