FAST-FORWARD vs HAI5

NCT06345534 | Recruiting

• 1 other identifier: ONZ-2023-0255
• Study Type: interventional
• Target: 740
• Locations: 1 country
• Sites: 2

Brief Summary

Randomized comparison between the FAST-FORWARD schedule and the HAI5 schedule for breast cancer radiotherapy in 5 fractions.

Conditions

Cancer, Breast

Outcome Measures

Primary Outcomes (1)

• Early side effects

  To evaluate radiotherapy-related symptoms in the chest/chest wall weekly up to 6 weeks after radiotherapy, evaluated with the standardized EORTC QLQ-BR23 questionnaire.

  Weekly up to 6 weeks after radiotherapy

Study Arms (2)

FAST-FORWARD schedule

OTHER

The first group is treated according to the FAST-FORWARD schedule, consisting of 5 radiation sessions on 5 consecutive working days (e.g. Monday to Friday). 2 rest days are allowed in the schedule, so that the treatment lasts a maximum of 7 days.

Device: Questionnaire

HAI5 schedule

OTHER

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.

Device: Questionnaire

Interventions

Questionnaire DEVICE

Patients will be asked to complete questionnaires at different times (before, during and after radiation) to evaluate which schedule gives the fewest side effects and the best quality of life. The basic questionnaire and questionnaire about early side effects will be completed weekly up to 6 weeks after radiotherapy. The questionnaire about late side effects will be completed: after 6 months, 1 year, 2 years, 3 years, 4 years and 5 years.

FAST-FORWARD schedule; HAI5 schedule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histopathological diagnosis of breast cancer
• age 18 years or older
• male or female
• treated with breast conserving surgery or mastectomy with curative intent
• multidisciplinary decision of adjuvant radiotherapy after surgery

You may not qualify if:

• distant metastases
• decision of preoperative radiotherapy
• decision of partial breast irradiation
• positive resection margins ('ink on tumour')
• indication for boost on lymph node(s)
• history of thoracic or ipsilateral axillary radiotherapy (including radiotherapy of the contralateral breast or chest wall)
• need for bilateral irradiation
• breast reconstruction or expander
• patients unlikely to comply with the protocol (e.g. inability or unwillingness to complete the questionnaires at different time points).

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (2)

Universitary Hospital

Ghent, 9000, Belgium

NOT YET RECRUITING

University Hospital Ghent

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Liv Veldeman, MD, PhD

  UZ Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liv Veldeman, MD, PhD

CONTACT

09 332 30 15; liv.veldeman@uzgent.be

Emma Van Damme

CONTACT

09 332 19 53; emma.vandamme@uzgent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Both healthcare provider and patient know the treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients participating in the study will be randomized 1:1 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 (e.g. Monday to Friday). 2 rest days are allowed in the schedule, 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 Record Dates

• First Submitted: March 14, 2024
• First Posted: April 3, 2024
• Study Start: May 30, 2024
• Primary Completion (Estimated): December 31, 2033
• Study Completion (Estimated): December 31, 2033
• Last Updated: June 5, 2024

Record last verified: 2024-06

Locations

BE (2)