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OpenTrials
Completed

NCT Number: NCT01978756

Outpatient Clinic for Late Outcome for Breast Carcinoma in MAASTRO Clinic.

In order to evaluate the late outcome in patients curatively treated for breast cancer, a special outpatient clinic will be developed.

There are two main purposes of the outpatient clinic. The first purpose is evaluating the results of the radiation treatment by mapping A) late toxicity and B) tumour control and survival.

The second purpose is that this outpatient clinic for late outcome will also function as a pilot for a new CAT (Computer Assisted Theragnostics, abbreviated CAT project) in which multiple late outcome variables will be recorded. In this pilot we want to investigate whether physical presence of the patient on the outpatient clinic, allowing physical examination, has any added value to the questionnaires filled in by the patient at home.

The ultimate aim of this new CAT project is to use these multicentric data to develop models for predicting both oncological outcome and late side effects. Insight in the beneficial and adverse effects of a certain treatment using these predictive models, will be required choose the optimal treatment for the individual patient using a shared decision making process.

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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

MAASTRO clinic

Maastricht, Limburg, 6200 XW, Netherlands

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients treated for breast cancer with curative intent in MAASTRO clinic in 2002-2003 who are still alive.
  • Consent to invitation letter and willing to participate.

Exclusion criteria

  • Treatment without curative intent.
  • No consent to invitation letter

Treatment and study plan

Outpatient clinic

Other

The participants are seen at the outpatient clinic by a physician or a physician assistant. To analyse fibrosis clinical examination of the breast will be performed. To analyse shoulder function anteversion / retroversion, abduction / adduction and internal / external rotation will be measured. To analyse edema the arm circumference will be measured 15 cm above and below the medial epicondyle (both sides). Also, a photograph of the breast will be made for cosmetic analysis using standardized procedures. Finally a blood sample or saliva will be obtained, if the patient has given written informed consent to participate in the Biobank.

Primary outcomes

  1. The primary endpoint is the incidence and severity of locoregional late toxicity at 10 years after radiotherapy.

    Time frame: One assessment approximately 10 years after radiotherapy

    As primary endpoint, for each patients the STAT score will be determined, summarizing locoregional late toxicity, e.g. fibrosis, cosmetic outcome, shoulder dysfunction, lymphedema arm, pain [Barnett et al, 2012].

Secondary outcomes

  1. The secondary endpoint is 10 year survival rate and the incidence and severity of other than locoregional late toxicity.

    Time frame: One assessment approximately 10 years after radiotherapy

    The secondary endpoint is 10 year survival rate, and late toxicity, other than locoregional late toxicity, e.g. fatigue, neuropathy, menopausal symptoms, cardiac and pulmonary symptoms, and secondary tumors. Survival will be divided in overall survival, locoregional recurrence free survival and distant metastases free survival. For each patient other toxicity at 10 year will be scored according to CTC-AE 4.

Other outcomes

  1. In addition, we will record potential risk factors for the several outcome parameters

    Time frame: one consultation by physician (assistant) ten years after radiotherapy

    The following the potential risk factors are recorded:

    • Patient related risk factors:
    • Age at time of diagnosis
    • Genetic and protein profile blood samples (optional with informed consent of participant)
    • Smoking
    • Treatment related factors:
    • Type of surgery
    • Excision volume
    • Post-operative complications
    • Resection margins Free
    • Scar visibility
    • Axillary surgery
    • Radiotherapy
    • Fractionation scheme
    • Target volumes
    • Dose-volume parameters
    • Actually delivered dose
    • Chemotherapy
    • Hormonal treatment
    • Immunotherapy
    • Tumor related factors
    • Localization
    • Stage
    • Differentiation grade
    • Hormonal receptors
    • HER-2
    • Genetic profile

Sponsors and collaborators

Lead sponsor

Maastricht Radiation Oncology

Other

Registry information

Official study title

Outpatient Clinic to Evaluate Late Outcome in Patients Curatively Treated for Breast Carcinoma in MAASTRO Clinic.

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 7, 2013
Registry last updated
May 24, 2016

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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