Standard Follow-up Program (SFP) for Breast Cancer Patients

• Conditions: Breast Cancer

• Registration Number: NCT06429995
• Lead Sponsor: University Medical Center Groningen

Brief Summary

Motive:

In order to improve the treatment technique, a comprehensive follow-up program is needed to obtain all relevant patient, treatment and toxicity data from breast cancer patients.

Goal:to set-up and maintain a database containing treatment results in terms of tumor control, side effects, complications and patient-reported quality of life.

A standard database of patiënts receiving photon treatment will be created. These data are then linked to dose-volume data of radiotherapy, with the aim to build prediction models for both tumor control and toxicity after radio (chemo) therapy that can later be used for selecting patients for proton treatment.

To set-up and maintain a database containing treatment results in terms of tumor control, side effects, complications and patient-reported quality of life.

A standard database of patients receiving photon treatment will be created. These data are then linked to dose-volume data of radiotherapy, with the aim to build prediction models for both tumor control and toxicity after radio (chemo) therapy that can later be used for selecting patients for proton treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-01
• Study First Submitted: 2023-09-22
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-22
• Last Update Submitted: 2024-05-22
• Study First Posted: 2024-05-28
• Last Update Posted: 2024-05-28
• Primary Completion: 2030-01-01
• Study Completion: 2030-01-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 10000

Inclusion Criteria

• Patients with breast cancer Patients receiving a radiotherapy dose

Exclusion Criteria

• Failure to comply with any of the inclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Score of Acute toxicity	Before start of radiation therapy and during radiation therapy and at 2 weeks after last day of radiation therapy.	Acute Toxicity is measured with Common Terminology Criteria for Adverse Events (CTCAE).
Score of Late toxicity	At one and two years after last day of radiation therapy.	Late Toxicity is measured with Common Terminology Criteria for Adverse Events (CTCAE).

Secondary Outcome Measures

Name	Time	Method
Loco-regional tumor control	At 2 weeks after last day of radiation therapy and thereafter yearly, anticipated average 5-10 years.	Loco-regional tumor control
Overall survival	At 2 weeks after last day of radiation therapy and thereafter yearly, anticipated average 5-10 years.	Overall survival

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands