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Single Dose Ablative Radiation Treatment for Early-Stage Breast Cancer (ABLATIVE)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02316561
Recruitment Status : Completed
First Posted : December 15, 2014
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
K.R. Charaghvandi, UMC Utrecht

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Neoplasm Radiation: Single dose ablative radiotherapy Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Dose Ablative Preoperative Radiation Treatment for Early-Stage Breast Cancer in Elderly Patients
Actual Study Start Date : October 2014
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Single dose ablative radiotherapy
Eligible patients for single dose ablative radiotherapy according to inclusion and exclusion criteria
Radiation: Single dose ablative radiotherapy
A single dose ablative radiotherapy will be delivered prior to surgery




Primary Outcome Measures :
  1. Pathological complete response [ Time Frame: 6 months after radiotherapy ]

Secondary Outcome Measures :
  1. Radiological tumor response on MRI according to the RECIST criteria [ Time Frame: Within 1 week and 2, 4 and 6 months after radiotherapy ]
  2. Radiological tumor response on FDG-PET-CT according to the PERCIST criteria [ Time Frame: At 6 months after radiotherapy ]
  3. Quality of life according to EORTC QLQ-BR23 and EORTC QLQ-C30 questionnaires [ Time Frame: Until 10 years after radiotherapy ]
  4. Cosmetic results as assessed by patient questionnaire, radiation oncologist evaluation and BCCT.core software [ Time Frame: Until 10 years after radiotherapy ]
  5. Frailty assessment according to the Groningen Frailty Indicator [ Time Frame: Until 10 years after radiotherapy ]
  6. Functionality assessment using patient questionnaires on physical activity and the Hospital Anxiety and Depression Scale questionnaire. [ Time Frame: Until 10 years after radiotherapy ]
  7. Local relapse rates [ Time Frame: Until 10 years after radiotherapy ]
  8. Regional relapse rates [ Time Frame: Until 10 years after radiotherapy ]
  9. Distant relapse rates [ Time Frame: Until 10 years after radiotherapy ]
  10. Disease free survival [ Time Frame: Until 10 years after radiotherapy ]
  11. Overall survival [ Time Frame: Until 10 years after radiotherapy ]

Other Outcome Measures:
  1. Tumor related genetic characteristics associated with radiotherapy responsiveness [ Time Frame: Until 10 years after radiotherapy ]
    Future research proposal performed within 10 years after radiotherapy



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02316561


Locations
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Netherlands
University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
UMC Utrecht
Investigators
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Principal Investigator: HJGD van den Bongard, MD, PhD UMC Utrecht

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: K.R. Charaghvandi, MD, UMC Utrecht
ClinicalTrials.gov Identifier: NCT02316561    
Other Study ID Numbers: NL46017.041.13
First Posted: December 15, 2014    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases