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Completed

NCT Number: NCT02505906

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

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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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, 9700RB, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Simultaneous Integrated Boost Technique

Radiation

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Acronym: FUSIB

Important dates

Study start
2008
Primary completion
2017
Study completion
2017
First posted
Jul 22, 2015
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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