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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Radiation: Simultaneous Integrated Boost Technique

• Study Type: Observational
• Enrollment (Actual): 5043

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9700RB
    • University Medical Center Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with breast cancer treated with curative intent.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2008
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: July 15, 2015
• First Submitted That Met QC Criteria: July 20, 2015
• First Posted (Estimated): July 22, 2015

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Radiotherapy; Late toxicity; Simultaneous integrated boost (SIB)
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: SFP2008-06