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In summary, breast conserving therapy (BCT) is an effective, save and widely used treatment technique for early breast cancer. Radiotherapy has shown to give better local control and survival benefit and is an integrated part of BCT. The simultaneous integrated boost (SIB) technique is a new treatment technique in breast irradiation. In this technique the whole breast is irradiated simultaneous with boosting the tumour bed, as part of BCT. Late radiation-induced toxicity has not been investigated in patients treated with radiotherapy using this technique. Proposed study will study the late radiation-induced toxicity, describe patients-rated complaints, quality of life, survival and local control curves in patients treated for early breast cancer with breast-conserving surgery in combination with radiotherapy with the SIB technique as compared to sequential radiotherapy treatment.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simultaneous Integrated Boost Technique | Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Late radiation-induced toxicity (grade 2 or higher) | Toxicity score using Common Terminology for Adverse Events (CTCAE) | At 1 year after completion of radiation therapy |
| Late radiation-induced toxicity (grade 2 or higher) | Toxicity score using Common Terminology for Adverse Events (CTCAE) | At 2 years after completion of radiation therapy |
| Late radiation-induced toxicity (grade 2 or higher) | Toxicity score using Common Terminology for Adverse Events (CTCAE) | At 3 years after completion of radiation therapy |
| Late radiation-induced toxicity (grade 2 or higher) | Toxicity score using Common Terminology for Adverse Events (CTCAE) | At 4 years after completion of radiation therapy |
| Late radiation-induced toxicity (grade 2 or higher) | Toxicity score using Common Terminology for Adverse Events (CTCAE) | At 5 years after completion of radiation therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | At 1,2,3,4 and 5 years after completion of radiation therapy | |
| Patient-rated symptoms | Questionnaire: BCSCQ | At 1,2,3,4 and 5 years after completion of radiation therapy |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with breast cancer treated with curative intent.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Groningen | 9700RB | Netherlands |
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| Quality of life in breast cancer patients treated with radiotherapy after breast conserving surgery | Questionnaires: European Organization for Research and Treatment of Cancer Quality of Life - Core Questionnaire (EORTC QLQ-C30), Quality of Life Questionnaire - Breast Cancer Module (QLQ-BR23) and Adult Comorbidity Evaluation (ACE-27) | At 1,2,3,4 and 5 years after completion of radiation therapy |
| Recurrence (local) | Assessed by Mammography, MRI (optional). If indicated: chest X-ray, bone scan, ultrasound | At 1,2,3,4 and 5 years after completion of radiation therapy |
| Recurrence (regional) | Assessed by Mammography, MRI (optional). If indicated: chest X-ray, bone scan, ultrasound | At 1,2,3,4 and 5 years after completion of radiation therapy |
| Recurrence (distant metastasis) | Assessed by Mammography, MRI (optional). If indicated: chest X-ray, bone scan, ultrasound | At 1,2,3,4 and 5 years after completion of radiation therapy |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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