Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2025-12-24 @ 9:55 PM
NCT ID:
NCT06909032
Brief Summary:
For women undergoing radiotherapy following surgery for early-stage breast cancer, breast-related quality of life (BrQoL) is an important consideration. Treating only the part of the breast by radiation where the cancer has been surgically removed (partial breast irradiation or "PBI") rather than the whole breast (whole breast irradiation) can reduce the toxic effects of radiotherapy. This trial aims to evaluate whether there is a difference in patient-reported BrQoL between two total doses of radiation given in five treatments using PBI. If BrQOL for the higher dose of PBI is no worse than the lower dose, using the higher dose would be advised as best practice, given that it is more likely to be more effective in reducing the chance of cancer coming back in the breast than the lower dose.
Detailed Description:
Single-blind, phase III, multisite, randomised non-inferiority trial. PBI will be planned and treated as per the protocol using VMAT. The prescribed dose will be 30 Gy in 5 daily fractions (Arm A) or 26 Gy in 5 daily fractions (Arm B). Participants will be blinded to their treatment allocation.
Follow-up will be at the following time points:
* Eight weeks following the end of radiation
* Every six months post-randomisation for two years following randomisation
* Three years post-randomisation (final visit)
Assessments to be conducted at each time point are:
* Clinical assessment
* Completion of Patient-Reported Outcome Measures (PROMs)
* Mammogram and ultrasound (baseline and annually)
* Documentation of IBTR - classified as a true recurrence or Elsewhere
* Documentation of any other type of recurrence (regional, distant, opposite breast)
Recruitment is planned for three years with a three-year follow-up period for all patients.
Study:
NCT06909032
Study Brief:
Protocol Section:
NCT06909032