ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02505906
Recruitment Status : Recruiting
First Posted : July 22, 2015
Last Update Posted : December 22, 2017
Sponsor:
Information provided by (Responsible Party):
J.H. Maduro, 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.

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

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer




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 [ 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02505906


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

Responsible Party: J.H. Maduro, Dr., University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02505906     History of Changes
Other Study ID Numbers: SFP2008-06
First Posted: July 22, 2015    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017

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