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

Breast Cancer Clinical Trial

— SFPMAMMA  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06429995
• Other study ID #: SFP MAMMA
• Status: Enrolling by invitation
• Start date: January 1, 2008
• Est. completion date: January 1, 2030

Study information

• Verified date: May 2024
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10000
• Est. completion date: January 1, 2030
• Est. primary completion date: January 1, 2030
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Patients with breast cancer Patients receiving a radiotherapy dose

Exclusion Criteria:

• Failure to comply with any of the inclusion criteria

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• Radiotherapy

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hemoglobin (Hb)	Hb level (mmol/l) measured in blood	Before start of radiation therapy
Other	Hematocrit (Ht)	Ht levels (L/L) measured in blood	Before start of radiation therapy
Other	Leukocytes	Leukocytes + differential count (10E9/l) measured in blood	Before start of radiation therapy
Other	Creatinine	Creatinine levels (mmol/l) measured in blood	Before start of radiation therapy
Other	Estimated Glomerular filtration rate (eGFR)	eGFR calculated from creatinine levels (ml/min)	Before start of radiation therapy
Other	Urea	Urea levels (mmol/l) measured in blood	Before start of radiation therapy
Other	Hemoglobin A1c (HbA1c)	HbA1c levels (mmol/mol) measured in blood	Before start of radiation therapy
Other	Cholesterol	Cholesterol levels (mmol/L) measured in blood	Before start of radiation therapy
Other	High-densitiy-lipoprotein cholesterol (HDL cholesterol)	HDL cholesterol levels (mmol/L) measured in blood	Before start of radiation therapy
Other	Low-density-lipoprotein cholesterol (LDL cholesterol)	LDL cholesterol levels (mmol/L) measured in blood	Before start of radiation therapy
Other	Triglycerides	Triglycerides levels (mmol/L) measured in blood	Before start of radiation therapy
Other	High sensitive C-reactive protein (hsCRP)	HsCRP levels (mg/L) measured in blood	Before start of radiation therapy
Other	Thyroid stimulating hormone (TSH)	TSH levels (mU/L) measured in blood	Before start of radiation therapy, 1 and 2 years after radiation therapy
Other	Free Thyroxine-4 (FT4)	FT4 levels (pmol/L) measured in blood	Before start of radiation therapy, 1 and 2 years after radiation therapy
Other	Patient-rated Demographics measured with the baseline questionnaire on Demographics	Patient-rated demographics measured with the baseline questionnaire on Demographics (unvalidated questionnaire)	Before start of radiation therapy
Other	Patient-rated symptoms measured with the EORTC QLQ-BR23	Patient-rated symptoms are measured with the Quality of Life Questionnaire-BR23 (EORTC QLQ-BR23)	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
Other	Patient-rated symptoms measured with the BCSCQ	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))	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.
Other	Patient-rated symptoms measured with the questionnaire on Cardiovascular Diseases and Risk Factors and Lung Diseases (baseline)	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)	Before start of radiation therapy
Other	Patient-rated symptoms with the questionnaire on Cardiovascular Diseases and Risk Factors and Lung Diseases (follow up)	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)	6 and 12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years
Other	Patient-rated symptoms measured with the questionnaire on Performance Status	Patient-rated symptoms are measured with the questionnaire on Performance Status (unvalidated questionnaire)	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
Other	: Patient-rated symptoms measured with the questionnaire on Locoregional Tumor Control/New Primary Tumor	Patient-rated symptoms are measured with the questionnaire on Locoregional Tumor Control/New Primary Tumor (unvalidated questionnaire)	6 and 12 months after last day of radiation therapy and thereafter yearly, anticipated average 20 years
Other	Patient-rated Quality of Life measured with the EORTC QLQ-C30	Patient-rated quality of life is measured with the Quality-of-Life Questionnaire-C30 (EORTC QLQ-C30)	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
Other	Patient-rated Quality of Life measured with the EuroQoL-5D_5L	Patient-rated quality of life is measured with the EuroQol Health questionnaire 5-level version (EuroQoL-5D_5L)	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
Other	Patient-rated Quality of Life measured with EORTC QLQ-BR23	Patient-rated quality of life is measured with the Quality of Life Questionnaire-BR23 (EORTC QLQ-BR23).	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
Primary	Score of Acute toxicity	Acute Toxicity is measured with Common Terminology Criteria for Adverse Events (CTCAE).	Before start of radiation therapy and during radiation therapy and at 2 weeks after last day of radiation therapy.
Primary	Score of Late toxicity	Late Toxicity is measured with Common Terminology Criteria for Adverse Events (CTCAE).	At one and two years after last day of radiation therapy.
Secondary	Overall survival	Overall survival	At 2 weeks after last day of radiation therapy and thereafter yearly, anticipated average 5-10 years.
Secondary	Loco-regional tumor control	Loco-regional tumor control	At 2 weeks after last day of radiation therapy and thereafter yearly, anticipated average 5-10 years.