NCT02316561

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 15, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

July 20, 2018

Status Verified

July 1, 2018

Enrollment Period

3.5 years

First QC Date

October 10, 2014

Last Update Submit

July 18, 2018

Conditions

Breast Neoplasm

Outcome Measures

Primary Outcomes (1)

  • Pathological complete response

    6 months after radiotherapy

Secondary Outcomes (11)

  • Radiological tumor response on MRI according to the RECIST criteria

    Within 1 week and 2, 4 and 6 months after radiotherapy

  • Radiological tumor response on FDG-PET-CT according to the PERCIST criteria

    At 6 months after radiotherapy

  • Quality of life according to EORTC QLQ-BR23 and EORTC QLQ-C30 questionnaires

    Until 10 years after radiotherapy

  • Cosmetic results as assessed by patient questionnaire, radiation oncologist evaluation and BCCT.core software

    Until 10 years after radiotherapy

  • Frailty assessment according to the Groningen Frailty Indicator

    Until 10 years after radiotherapy

  • +6 more secondary outcomes

Other Outcomes (1)

  • Tumor related genetic characteristics associated with radiotherapy responsiveness

    Until 10 years after radiotherapy

Study Arms (1)

Single dose ablative radiotherapy

EXPERIMENTAL

Eligible patients for single dose ablative radiotherapy according to inclusion and exclusion criteria

Radiation: Single dose ablative radiotherapy

Interventions

Single dose ablative radiotherapyRADIATION

A single dose ablative radiotherapy will be delivered prior to surgery

Single dose ablative radiotherapy

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location

Related Publications (2)

  • Groot Koerkamp ML, de Hond YJM, Maspero M, Kontaxis C, Mandija S, Vasmel JE, Charaghvandi RK, Philippens MEP, van Asselen B, van den Bongard HJGD, Hackett SS, Houweling AC. Synthetic CT for single-fraction neoadjuvant partial breast irradiation on an MRI-linac. Phys Med Biol. 2021 Apr 16;66(8). doi: 10.1088/1361-6560/abf1ba.

    PMID: 33761491DERIVED

  • 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.

    PMID: 28274211DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • HJGD van den Bongard, MD, PhD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 10, 2014

First Posted

December 15, 2014

Study Start

October 1, 2014

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

July 20, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)