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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

Tracking Information
First Submitted Date  ICMJE October 10, 2014
First Posted Date  ICMJE December 15, 2014
Last Update Posted Date July 20, 2018
Actual Study Start Date  ICMJE October 2014
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2014)
Pathological complete response [ Time Frame: 6 months after radiotherapy ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2014)
  • Radiological tumor response on MRI according to the RECIST criteria [ Time Frame: Within 1 week and 2, 4 and 6 months after radiotherapy ]
  • Radiological tumor response on FDG-PET-CT according to the PERCIST criteria [ Time Frame: At 6 months after radiotherapy ]
  • Quality of life according to EORTC QLQ-BR23 and EORTC QLQ-C30 questionnaires [ Time Frame: Until 10 years after radiotherapy ]
  • Cosmetic results as assessed by patient questionnaire, radiation oncologist evaluation and BCCT.core software [ Time Frame: Until 10 years after radiotherapy ]
  • Frailty assessment according to the Groningen Frailty Indicator [ Time Frame: Until 10 years after radiotherapy ]
  • Functionality assessment using patient questionnaires on physical activity and the Hospital Anxiety and Depression Scale questionnaire. [ Time Frame: Until 10 years after radiotherapy ]
  • Local relapse rates [ Time Frame: Until 10 years after radiotherapy ]
  • Regional relapse rates [ Time Frame: Until 10 years after radiotherapy ]
  • Distant relapse rates [ Time Frame: Until 10 years after radiotherapy ]
  • Disease free survival [ Time Frame: Until 10 years after radiotherapy ]
  • Overall survival [ Time Frame: Until 10 years after radiotherapy ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 12, 2014)
Tumor related genetic characteristics associated with radiotherapy responsiveness [ Time Frame: Until 10 years after radiotherapy ]
Future research proposal performed within 10 years after radiotherapy
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Single Dose Ablative Radiation Treatment for Early-Stage Breast Cancer
Official Title  ICMJE Single Dose Ablative Preoperative Radiation Treatment for Early-Stage Breast Cancer in Elderly Patients
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasm
Intervention  ICMJE Radiation: Single dose ablative radiotherapy
A single dose ablative radiotherapy will be delivered prior to surgery
Study Arms  ICMJE Experimental: Single dose ablative radiotherapy
Eligible patients for single dose ablative radiotherapy according to inclusion and exclusion criteria
Intervention: Radiation: Single dose ablative radiotherapy
Publications * Charaghvandi RK, van Asselen B, Philippens ME, Verkooijen HM, van Gils CH, van Diest PJ, Pijnappel RM, Hobbelink MG, Witkamp AJ, van Dalen T, van der Wall E, van Heijst TC, Koelemij R, van Vulpen M, van den Bongard HJ. Redefining radiotherapy for early-stage breast cancer with single dose ablative treatment: a study protocol. BMC Cancer. 2017 Mar 9;17(1):181. doi: 10.1186/s12885-017-3144-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 12, 2014)
25
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2018
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02316561
Other Study ID Numbers  ICMJE NL46017.041.13
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party K.R. Charaghvandi, UMC Utrecht
Study Sponsor  ICMJE UMC Utrecht
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: HJGD van den Bongard, MD, PhD UMC Utrecht
PRS Account UMC Utrecht
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP