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

• ClinicalTrials.gov Identifier: NCT02505906
• Recruitment Status: Recruiting
• First Posted: July 22, 2015
• Last Update Posted: June 30, 2021
• Sponsor: University Medical Center Groningen
• Information provided by (Responsible Party): J.H. Maduro, University Medical Center Groningen

Study Description

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.

Condition or disease	Intervention/treatment
Breast Cancer	Radiation: Simultaneous Integrated Boost Technique

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 10000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 5 Years
• Study Start Date: January 2008
• Estimated Primary Completion Date: January 2025
• Estimated Study Completion Date: January 2025

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Late radiation-induced toxicity (grade 2 or higher) [ Time Frame: At 1 year after completion of radiation therapy ]
   Toxicity score using Common Terminology for Adverse Events (CTCAE)
2. Late radiation-induced toxicity (grade 2 or higher) [ Time Frame: At 2 years after completion of radiation therapy ]
   Toxicity score using Common Terminology for Adverse Events (CTCAE)
3. Late radiation-induced toxicity (grade 2 or higher) [ Time Frame: At 3 years after completion of radiation therapy ]
   Toxicity score using Common Terminology for Adverse Events (CTCAE)
4. Late radiation-induced toxicity (grade 2 or higher) [ Time Frame: At 4 years after completion of radiation therapy ]
   Toxicity score using Common Terminology for Adverse Events (CTCAE)
5. Late radiation-induced toxicity (grade 2 or higher) [ Time Frame: At 5 years after completion of radiation therapy ]
   Toxicity score using Common Terminology for Adverse Events (CTCAE)

Secondary Outcome Measures :

1. Overall survival [ Time Frame: At 1,2,3,4 and 5 years after completion of radiation therapy ]
2. Patient-rated symptoms [ Time Frame: At 1,2,3,4 and 5 years after completion of radiation therapy ]
   Questionnaire: BCSCQ
3. Quality of life in breast cancer patients treated with radiotherapy after breast conserving surgery [ Time Frame: 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)
4. Recurrence (local) [ Time Frame: 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
5. Recurrence (regional) [ Time Frame: 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
6. Recurrence (distant metastasis) [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients with breast cancer treated with curative intent.

Criteria

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.

Contacts and Locations

Contacts

Contact: J.H. Maduro, Drs.; +31503619375; j.h.maduro@umcg.nl

Locations

Netherlands

University Medical Center Groningen; Recruiting

Groningen, Netherlands, 9700RB

Contact: JH Maduro, Dr. +31503619375 j.h.maduro@umcg.nl

Sponsors and Collaborators

University Medical Center Groningen

More Information

Additional Information:

• Responsible Party: J.H. Maduro, Dr., University Medical Center Groningen
• ClinicalTrials.gov Identifier: NCT02505906
• Other Study ID Numbers: SFP2008-06
• First Posted: July 22, 2015
• Last Update Posted: June 30, 2021
• Last Verified: June 2021

Keywords provided by J.H. Maduro, University Medical Center Groningen:

Late toxicity; Simultaneous integrated boost (SIB); Radiotherapy

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases