Late Toxicity in Breast Cancer Patients Treated With Breast-conserving Surgical Procedures and Radiotherapy Using the Simultaneous Integrated Boost Technique

Completed

• Conditions: Breast Cancer

• Registration Number: NCT02505906
• Lead Sponsor: University Medical Center Groningen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2015-07-15
• Study First Submitted QC: 2015-07-20
• Study First Posted: 2015-07-22
• Primary Completion: 2017-09-01
• Study Completion: 2017-09-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 5043

Inclusion Criteria

• WHO performance status 0-2.
• Invasive breast cancer or ductal carcinoma in situ (DCIS).
• Stage I-III breast cancer or DCIS.
• Treated with curative radiotherapy of the breast (as part of breast conserving therapy) with simultaneous integrated boost technique, with or without irradiation of the regional (including internal mammary) lymph nodes.

Exclusion Criteria

• Previous thoracic radiotherapy.
• Previous history of malignancy, except adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin.
• Bilateral (synchrone) invasive breast cancer.
• Treatment prior to surgery (i.e. neoadjuvant chemotherapy, neoadjuvant hormonal therapy, pre-operative radiotherapy).
• Distant metastases at diagnosis (M1).
• Unsufficient knowledge of Dutch language.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Late radiation-induced toxicity (grade 2 or higher)	At 5 years after completion of radiation therapy	Toxicity score using Common Terminology for Adverse Events (CTCAE)

Secondary Outcome Measures

Name	Time	Method
Overall survival	At 1,2,3,4 and 5 years after completion of radiation therapy
Recurrence (local)	At 1,2,3,4 and 5 years after completion of radiation therapy	Assessed by Mammography, MRI (optional). If indicated: chest X-ray, bone scan, ultrasound
Quality of life in breast cancer patients treated with radiotherapy after breast conserving surgery	At 1,2,3,4 and 5 years after completion of radiation therapy	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)
Recurrence (regional)	At 1,2,3,4 and 5 years after completion of radiation therapy	Assessed by Mammography, MRI (optional). If indicated: chest X-ray, bone scan, ultrasound
Patient-rated symptoms	At 1,2,3,4 and 5 years after completion of radiation therapy	Questionnaire: BCSCQ
Recurrence (distant metastasis)	At 1,2,3,4 and 5 years after completion of radiation therapy	Assessed by Mammography, MRI (optional). If indicated: chest X-ray, bone scan, ultrasound

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands