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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02316561
Other study ID # NL46017.041.13
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2014
Est. completion date April 2018

Study information

Verified date July 2018
Source UMC Utrecht
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to investigate the feasibility of a preoperative, single dose, ablative partial breast radiation treatment in patients with early-stage breast cancer.


Description:

A total of twenty-five patients will be treated with a single dose preoperative ablative radiation treatment. After a vigilant follow-up with MRI, breast conserving surgery will be performed 6 months after the ablative radiation treatment. The total follow-up time is 10 years.

This study aims to present an ablative radiotherapy treatment approach that could resolve to some extent the disadvantages of current breast conserving treatment in elderly low-risk breast cancer patients who are currently not treated according to guidelines due to co-morbidity.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date April 2018
Est. primary completion date April 2018
Accepts healthy volunteers No
Gender Female
Age group 50 Years and older
Eligibility Inclusion Criteria:

- WHO performance scale =2.

- Females at least 50 years of age with unifocal cT1N0 breast cancer or females at least 70 years of age with an unifocal cT1-2(maximum 3 cm)N0 breast cancer:

- Tumor size as assessed on MRI

- On tumor biopsy:

- Non-lobular invasive histological type carcinoma.

- LCIS is accepted.

- ER positive tumor receptor.

- Tumor negative sentinel node.

- Adequate communication and understanding skills of the Dutch language.

Exclusion Criteria:

- Legal incapacity

- Indication for chemotherapy or immunotherapy (i.e. patients with an indication for endocrine therapy are eligible)

- BRCA gene mutation.

- Previous history of breast cancer

- Other type of malignancy within 5 years before breast cancer diagnosis. For adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin no specific time span from breast cancer diagnosis is required for inclusion

- Her2neu positive tumor.

- Previous history of ipsilateral breast surgery and impaired cosmetic outcome, as assessed by the treating surgeon or radiation-oncologist.

- Collagen synthesis disease.

- Signs of extensive DCIS component on histological biopsy or mammogram.

- Invasive lobular carcinoma.

- MRI absolute contraindications as defined by the Radiology Department.

- Nodal involvement with cytological or histological confirmation.

- Treatment with neo-adjuvant systemic therapy.

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
Single dose ablative radiotherapy
A single dose ablative radiotherapy will be delivered prior to surgery

Locations

Country Name City State
Netherlands University Medical Center Utrecht Utrecht

Sponsors (1)

Lead Sponsor Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Other Tumor related genetic characteristics associated with radiotherapy responsiveness Future research proposal performed within 10 years after radiotherapy Until 10 years after radiotherapy
Primary Pathological complete response 6 months after radiotherapy
Secondary Radiological tumor response on MRI according to the RECIST criteria Within 1 week and 2, 4 and 6 months after radiotherapy
Secondary Radiological tumor response on FDG-PET-CT according to the PERCIST criteria At 6 months after radiotherapy
Secondary Quality of life according to EORTC QLQ-BR23 and EORTC QLQ-C30 questionnaires Until 10 years after radiotherapy
Secondary Cosmetic results as assessed by patient questionnaire, radiation oncologist evaluation and BCCT.core software Until 10 years after radiotherapy
Secondary Frailty assessment according to the Groningen Frailty Indicator Until 10 years after radiotherapy
Secondary Functionality assessment using patient questionnaires on physical activity and the Hospital Anxiety and Depression Scale questionnaire. Until 10 years after radiotherapy
Secondary Local relapse rates Until 10 years after radiotherapy
Secondary Regional relapse rates Until 10 years after radiotherapy
Secondary Distant relapse rates Until 10 years after radiotherapy
Secondary Disease free survival Until 10 years after radiotherapy
Secondary Overall survival Until 10 years after radiotherapy
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