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Comparing 5 and 15 Fractions for Whole Breast Irradiation After Breast Conserving Surgery

NCT03677427 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 488

Last updated 2024-03-05

No results posted yet for this study

Summary

Adjuvant radiotherapy after breast-conserving surgery for breast cancer reduces the risk of locoregional relapse and ensures better overall survival. In recent years it has been found that hypofractionation in which the number of radiation sessions is reduced with a higher dose per session offers advantages for breast irradiation. Randomized studies showed that moderate hypofraction regimens in 15 or 16 fractions have the same effect in tumor control and toxicity, although the total dose is lower than the traditional 50 Gy in 25 fractions. In a randomized study from the United Kingdom (START-B trial) even a better disease-free survival was seen with 15 sessions than with 25 sessions and the long-term side effects were also less with the short schedule.

This project proposes a clinical trial with an accelerated radiotherapy schedule in 5 sessions. It is expected that the accelerated schedule of 5 sessions over 12 days will have a number of radiobiological benefits: since a higher dose per session is given over a shorter period of time, it is expected that tumor control and survival will be higher. By reducing the total treatment time, the total dose is reduced, which may result in fewer radiation-related side effects and thus improve the quality of life. Apart from these radiobiological benefits, the shorter radiotherapy program reduces the number of treatment days from 15 to 5. This is not only more comfortable for the patients, but also increases the treatment capacity of the radiotherapy department. This opens up a possibility for the use of more complex techniques with fewer side effects such as radiation in the prone position.

This project includes a randomized study comparing the accelerated schedule in 5 sessions with a hypofraction schedule of 15 sessions in patients who are irradiated on the entire breast after breast-saving surgery. The primary endpoint is chest retraction (loss of volume) 2 years after radiotherapy.

Conditions

Interventions

RADIATION

Radiation

Radiation in breast cancer

Sponsors & Collaborators

  • Kom Op Tegen Kanker

    collaborator OTHER

  • University Hospital, Ghent

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-16
Primary Completion
2023-06-23
Completion
2023-06-23

Countries

  • Belgium

Study Locations

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Entities

Diseases

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 NCT03677427 on ClinicalTrials.gov