Skip to main content
OpenTrials
Completed

NCT Number: NCT01973634

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Radiotherapy After Breast Conserving Surgery

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Ghent University Hospital

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Female patients AND breast conserving surgery AND multidisciplinary decision of adjuvant WBI with a boost to the tumor bed AND age ≥ 18 years AND informed consent obtained, signed and dated before specific protocol procedures

Exclusion criteria

  • Mastectomy
  • Need for lymph node irradiation
  • No boost
  • Bilateral breast irradiation
  • Patient not able to reach or maintain the prone position
  • Pregnant or breastfeeding
  • Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
  • Patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study

Treatment and study plan

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

Radiation

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

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

Radiation

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)

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

Radiation

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

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

Radiation

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

Primary outcomes

  1. Degree of acute moist desquamation during or in the first 2 weeks after radiotherapy.

    Time frame: weekly during radiotherapy, 2 weeks after the end of radiotherapy.

    Clinical inspection of the treated breast.

Secondary outcomes

  1. Degree of acute skin toxicity.

    Time frame: Weekly during radiotherapy and 2 weeks after the end of radiotherapy.

    Clinical inspection.

  2. Degree of chronic skin toxicity and cosmesis after radiotherapy.

    Time frame: 2 weeks, 1 year, 2 years and 5 years after radiotherapy.

    Inspection, clinical evaluation, digital photographs.

  3. Quality of life after radiotherapy.

    Time frame: 2 weeks, 1 year, 2 years and 5 years after radiotherapy.

    QLQ C30 and QLQ BR23 quality of life questionnaires.

  4. Biomarker analysis.

    Time frame: Blood sample within 1 week before the start of radiotherapy

    Blood sample

  5. Measurement of costs for the patient for the full treatment.

    Time frame: Over the period of radiotherapy treatment, with a maximum of 5 weeks.

    Activity based costing models.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Acronym: SeqB vs SIB

Important dates

Study start
2012
Primary completion
2015
Study completion
2021
First posted
Oct 31, 2013
Registry last updated
Dec 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.