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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01978756
• Other study ID #: 12-25-15/08
• Status: Completed
• Phase: N/A
• First received: September 2, 2013
• Last updated: May 23, 2016
• Start date: March 2013
• Est. completion date: January 2015

Study information

• Verified date: May 2016
• Source: Maastricht Radiation Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 387
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Outpatient clinic
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.

Locations

Country	Name	City	State
Netherlands	MAASTRO clinic	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht Radiation Oncology

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	In addition, we will record potential risk factors for the several outcome parameters	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	one consultation by physician (assistant) ten years after radiotherapy	No
Primary	The primary endpoint is the incidence and severity of locoregional late toxicity at 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].	One assessment approximately 10 years after radiotherapy	No
Secondary	The secondary endpoint is 10 year survival rate and the incidence and severity of other than locoregional late toxicity.	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.	One assessment approximately 10 years after radiotherapy	No