Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06345534
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-03-14
Brief Title:
FAST-FORWARD vs HAI5
Sponsor:
University Hospital Ghent
Organization:
University Hospital Ghent
Study Overview
Official Title:
Randomized Comparison Between the FAST-FORWARD Schedule and the HAI5 Schedule for Breast Cancer Radiotherapy in 5 Fractions
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Randomized comparison between the FAST-FORWARD schedule and the HAI5 schedule for breast cancer radiotherapy in 5 fractions
Detailed Description:
Previously radiotherapy treatments for breast cancer usually consisted of 20-25 sessions to treat the entire breast followed by an additional dose boost to the tumor bed of 4-8 sessions Today 15-16 treatment sessions have become standard for whole breast irradiation followed by a boost if indicated The durability of further shortening the treatment to 5 sessions was proven in the FAST and FAST-FORWARD studies After 10 and 5 years the outcome was comparable with 25 and 15 radiation sessions both in terms of toxicity and locoregional control
There are currently 2 radiotherapy schedules in 5 sessions in use in Belgium the FAST-FORWARD schedule and the HAI5 schedule both of which have their advantages and disadvantages In this project we want to investigate which schedule gives the fewest side effects and the best quality of life using questionnaires at different times before during and after radiation
Patients participating in the study will be randomized 11 between the FAST-FORWARD schedule and the HAI5 schedule The first group is treated according to the FAST-FORWARD schedule consisting of 5 radiation sessions on 5 consecutive working days eg Monday to Friday In the schedule 2 rest days are allowed so that the treatment lasts a maximum of 7 days The second group is treated according to the HAI5 schedule developed by the radiotherapy department of Ghent University Hospital In this schedule at least 1 day of rest is scheduled between each treatment session so the treatment is administered over 10-14 days
There are currently 2 radiotherapy schedules in 5 sessions in use in Belgium the FAST-FORWARD schedule and the HAI5 schedule both of which have their advantages and disadvantages In this project we want to investigate which schedule gives the fewest side effects and the best quality of life using questionnaires at different times before during and after radiation
Patients participating in the study will be randomized 11 between the FAST-FORWARD schedule and the HAI5 schedule The first group is treated according to the FAST-FORWARD schedule consisting of 5 radiation sessions on 5 consecutive working days eg Monday to Friday In the schedule 2 rest days are allowed so that the treatment lasts a maximum of 7 days The second group is treated according to the HAI5 schedule developed by the radiotherapy department of Ghent University Hospital In this schedule at least 1 day of rest is scheduled between each treatment session so the treatment is administered over 10-14 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None