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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Overall survival | At 2 weeks after last day of radiation therapy and thereafter yearly, anticipated average 5-10 years. |
| Loco-regional tumor control | Loco-regional tumor control |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin (Hb) | Hb level (mmol/l) measured in blood | Before start of radiation therapy |
| Hematocrit (Ht) | Ht levels (L/L) measured in blood | Before start of radiation therapy |
Inclusion Criteria:
Exclusion Criteria:
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Patients with breast cancer receiving radiotherapy
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| Name | Affiliation | Role |
|---|---|---|
| Anne Crijns, MD, PhD | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Groningen | 9700RB | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11413515 | Background | 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. | |
| 1470691 | Background | 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D003131 | Combined Modality Therapy |
| D004358 | Drug Therapy |
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| At 2 weeks after last day of radiation therapy and thereafter yearly, anticipated average 5-10 years. |
| Leukocytes | Leukocytes + differential count (10E9/l) measured in blood | Before start of radiation therapy |
| Creatinine | Creatinine levels (mmol/l) measured in blood | Before start of radiation therapy |
| Estimated Glomerular filtration rate (eGFR) | eGFR calculated from creatinine levels (ml/min) | Before start of radiation therapy |
| Urea | Urea levels (mmol/l) measured in blood | Before start of radiation therapy |
| Hemoglobin A1c (HbA1c) | HbA1c levels (mmol/mol) measured in blood | Before start of radiation therapy |
| Cholesterol | Cholesterol levels (mmol/L) measured in blood | Before start of radiation therapy |
| High-densitiy-lipoprotein cholesterol (HDL cholesterol) | HDL cholesterol levels (mmol/L) measured in blood | Before start of radiation therapy |
| Low-density-lipoprotein cholesterol (LDL cholesterol) | LDL cholesterol levels (mmol/L) measured in blood | Before start of radiation therapy |
| Triglycerides | Triglycerides levels (mmol/L) measured in blood | Before start of radiation therapy |
| High sensitive C-reactive protein (hsCRP) | HsCRP levels (mg/L) measured in blood | Before start of radiation therapy |
| Thyroid stimulating hormone (TSH) | TSH levels (mU/L) measured in blood | Before start of radiation therapy, 1 and 2 years after radiation therapy |
| Free Thyroxine-4 (FT4) | FT4 levels (pmol/L) measured in blood | Before start of radiation therapy, 1 and 2 years after radiation therapy |
| 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 |
| 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 |
| 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. |
| 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 |
| 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 |
| 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 |
| : 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 |
| 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 |
| 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 |
| 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 |
| D017437 |
| Skin and Connective Tissue Diseases |