Standard Follow-up Program (SFP) for Breast Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Radiotherapy.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 18 years — 99 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Radiation Radiotherapy
Primary outcome measures
- Score of Acute toxicity [Time frame: Before start of radiation therapy and during radiation therapy and at 2 weeks after last day of radiation therapy.]
- Score of Late toxicity [Time frame: At one and two years after last day of radiation therapy.]
Secondary outcome measures (2)
- Overall survival [Time frame: At 2 weeks after last day of radiation therapy and thereafter yearly, anticipated average 5-10 years.]
- Loco-regional tumor control [Time frame: At 2 weeks after last day of radiation therapy and thereafter yearly, anticipated average 5-10 years.]
Eligibility criteria
Inclusion criteria
- Patients with breast cancer Patients receiving a radiotherapy dose
Exclusion criteria
- Failure to comply with any of the inclusion criteria
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- University Medical Center Groningen — Groningen
Publications
- Stanton AL, Krishnan L, Collins CA. Form or function? Part 1. Subjective cosmetic and functional correlates of quality of life in women treated with breast-conserving surgical procedures and radiotherapy. Cancer. 2001 Jun 15;91(12):2273-81. PMID 11413515
- Sneeuw KC, Aaronson NK, Yarnold JR, Broderick M, Regan J, Ross G, Goddard A. Cosmetic and functional outcomes of breast conserving treatment for early stage breast cancer. 1. Comparison of patients' ratings, observers' ratings, and objective assessments. Radiother Oncol. 1992 Nov;25(3):153-9. doi: 10.1016/0167-8140(92)90261-r. PMID 1470691
Identifiers
NCT: NCT06429995 · SFP MAMMA