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Enrolling by Invitation

NCT Number: NCT06429995

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

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.

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

Female

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, 9700RB, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with breast cancer Patients receiving a radiotherapy dose

Exclusion criteria

  • Failure to comply with any of the inclusion criteria

Treatment and study plan

Radiotherapy

Radiation

Other names: chemoradiation

Primary outcomes

  1. 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.

    Acute Toxicity is measured with Common Terminology Criteria for Adverse Events (CTCAE).

  2. Score of Late toxicity

    Time frame: At one and two years after last day of radiation therapy.

    Late Toxicity is measured with Common Terminology Criteria for Adverse Events (CTCAE).

Secondary outcomes

  1. Overall survival

    Time frame: At 2 weeks after last day of radiation therapy and thereafter yearly, anticipated average 5-10 years.

    Overall survival

  2. Loco-regional tumor control

    Time frame: At 2 weeks after last day of radiation therapy and thereafter yearly, anticipated average 5-10 years.

    Loco-regional tumor control

Other outcomes

  1. Hemoglobin (Hb)

    Time frame: Before start of radiation therapy

    Hb level (mmol/l) measured in blood

  2. Hematocrit (Ht)

    Time frame: Before start of radiation therapy

    Ht levels (L/L) measured in blood

  3. Leukocytes

    Time frame: Before start of radiation therapy

    Leukocytes + differential count (10E9/l) measured in blood

  4. Creatinine

    Time frame: Before start of radiation therapy

    Creatinine levels (mmol/l) measured in blood

  5. Estimated Glomerular filtration rate (eGFR)

    Time frame: Before start of radiation therapy

    eGFR calculated from creatinine levels (ml/min)

  6. Urea

    Time frame: Before start of radiation therapy

    Urea levels (mmol/l) measured in blood

  7. Hemoglobin A1c (HbA1c)

    Time frame: Before start of radiation therapy

    HbA1c levels (mmol/mol) measured in blood

  8. Cholesterol

    Time frame: Before start of radiation therapy

    Cholesterol levels (mmol/L) measured in blood

  9. High-densitiy-lipoprotein cholesterol (HDL cholesterol)

    Time frame: Before start of radiation therapy

    HDL cholesterol levels (mmol/L) measured in blood

  10. Low-density-lipoprotein cholesterol (LDL cholesterol)

    Time frame: Before start of radiation therapy

    LDL cholesterol levels (mmol/L) measured in blood

  11. Triglycerides

    Time frame: Before start of radiation therapy

    Triglycerides levels (mmol/L) measured in blood

  12. High sensitive C-reactive protein (hsCRP)

    Time frame: Before start of radiation therapy

    HsCRP levels (mg/L) measured in blood

  13. Thyroid stimulating hormone (TSH)

    Time frame: Before start of radiation therapy, 1 and 2 years after radiation therapy

    TSH levels (mU/L) measured in blood

  14. Free Thyroxine-4 (FT4)

    Time frame: Before start of radiation therapy, 1 and 2 years after radiation therapy

    FT4 levels (pmol/L) measured in blood

  15. Patient-rated Demographics measured with the baseline questionnaire on Demographics

    Time frame: Before start of radiation therapy

    Patient-rated demographics measured with the baseline questionnaire on Demographics (unvalidated questionnaire)

  16. Patient-rated symptoms measured with the EORTC QLQ-BR23

    Time frame: Before start of radiation therapy, at 2 weeks after last day of radiation therapy, and at 3,6,12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years

    Patient-rated symptoms are measured with the Quality of Life Questionnaire-BR23 (EORTC QLQ-BR23)

  17. Patient-rated symptoms measured with the BCSCQ

    Time frame: Before start of radiation therapy, at 2 weeks after last day of radiation therapy, and at 3,6,12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years.

    Patient-rated symptoms are measured with the Breast Cancer Questionnaire (BCSCQ: Based on the BCTOS (1) and the questionnaire on Patients' satisfaction with the cosmetic outcome by Sneeuw at al.(2))

  18. Patient-rated symptoms measured with the questionnaire on Cardiovascular Diseases and Risk Factors and Lung Diseases (baseline)

    Time frame: Before start of radiation therapy

    Patient-rated symptoms are measured with the baseline questionnaire on Cardiovascular Diseases and Risk Factors and Lung Diseases before start of radiation therapy (unvalidated questionnaire)

  19. Patient-rated symptoms with the questionnaire on Cardiovascular Diseases and Risk Factors and Lung Diseases (follow up)

    Time frame: 6 and 12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years

    Patient-rated symptoms are measured with the follow up questionnaire on Cardiovascular Diseases and Risk Factors and Lung Diseases (semi)annually after last day of radiation therapy (unvalidated questionnaire)

  20. Patient-rated symptoms measured with the questionnaire on Performance Status

    Time frame: Before start of radiation therapy, at 2 weeks after last day of radiation therapy, and at 3,6,12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years

    Patient-rated symptoms are measured with the questionnaire on Performance Status (unvalidated questionnaire)

  21. : Patient-rated symptoms measured with the questionnaire on Locoregional Tumor Control/New Primary Tumor

    Time frame: 6 and 12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years

    Patient-rated symptoms are measured with the questionnaire on Locoregional Tumor Control/New Primary Tumor (unvalidated questionnaire)

  22. Patient-rated Quality of Life measured with the EORTC QLQ-C30

    Time frame: Before start of radiation therapy, at 2 weeks after last day of radiation therapy, and at 3,6,12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years

    Patient-rated quality of life is measured with the Quality-of-Life Questionnaire-C30 (EORTC QLQ-C30)

  23. Patient-rated Quality of Life measured with the EuroQoL-5D_5L

    Time frame: Before start of radiation therapy, at 2 weeks after last day of radiation therapy, and at 3,6,12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years

    Patient-rated quality of life is measured with the EuroQol Health questionnaire 5-level version (EuroQoL-5D_5L)

  24. Patient-rated Quality of Life measured with EORTC QLQ-BR23

    Time frame: Before start of radiation therapy, at 2 weeks after last day of radiation therapy, and at 3,6,12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years

    Patient-rated quality of life is measured with the Quality of Life Questionnaire-BR23 (EORTC QLQ-BR23).

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Acronym: SFPMAMMA

Important dates

Study start
2008
Primary completion
2030
Study completion
2030
First posted
May 28, 2024
Registry last updated
May 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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