NCT03677427

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
488

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 16, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2017

Completed
9 months until next milestone

First Posted

Study publicly available on registry

September 19, 2018

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2023

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

5.7 years

First QC Date

December 22, 2017

Last Update Submit

March 4, 2024

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • radiation-induced breast retraction

    The primary endpoint of the randomized trial is radiation-induced breast retraction (volume loss) measured 2 years after radiotherapy.$

    4 years

Secondary Outcomes (14)

  • Acute breast toxicity: dermatitis

    2 years

  • Acute breast toxicity: desquamation

    2 years

  • Acute breast toxicity: breast oedema

    2 years

  • Acute breast toxicity: breast symptoms

    2 years

  • Acute breast toxicity: dyspnoea

    2 years

  • +9 more secondary outcomes

Study Arms (2)

5 fractions

EXPERIMENTAL
Radiation: Radiation

15 fractions

EXPERIMENTAL
Radiation: Radiation

Interventions

RadiationRADIATION

Radiation in breast cancer

15 fractions5 fractions

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsIt's a study on breast cancer in female patients
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • female patients with non-metastatic breast cancer,
  • age ≥ 18 years,
  • breast conserving surgery,
  • multidisciplinary decision of adjuvant breast irradiation,
  • informed consent obtained, signed and dated before specific protocol procedures

You may not qualify if:

  • lymph node metastases,
  • distant metastases,
  • bilateral breast irradiation,
  • history of previous radiation treatment to the same region
  • life expectancy of less than 2 years,
  • planned reconstructive surgery,
  • conditions making toxicity evaluation difficult (e.g. skin disorders),
  • inability to respect constraints on organs at risks
  • patients unlikely to comply with the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radiotherapie UZ Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2017

First Posted

September 19, 2018

Study Start

October 16, 2017

Primary Completion

June 23, 2023

Study Completion

June 23, 2023

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)