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

Breast Cancer Clinical Trial

— FUSIB  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02505906
• Other study ID #: SFP2008-06
• Status: Completed
• Start date: January 2008
• Est. completion date: September 1, 2017

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5043
• Est. completion date: September 1, 2017
• Est. primary completion date: September 1, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• Simultaneous Integrated Boost Technique

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Overall survival		At 1,2,3,4 and 5 years after completion of radiation therapy
Secondary	Patient-rated symptoms	Questionnaire: BCSCQ	At 1,2,3,4 and 5 years after completion of radiation therapy
Secondary	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
Secondary	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
Secondary	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
Secondary	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