Geometric accuracy of accelerated partial breast irradiation on the Cyberknife using standard surgical clips as a fiducial marker

Geometric accuracy of accelerated partial breast irradiation on the Cyberknife using standard surgical clips as a fiducial marker - CK-APBI

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48772

Enrollment

Registered

2018-03-14

Start date

2018-11-09

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer breast carcinoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Female - Age * 50 years - Stage pTis, pT1 or pT2 (tumor size

Exclusion criteria

Exclusion criteria: - Lympho-vascular infiltration - Extensive intraductal component - Multifocal or multicentric disease - Invasive lobular carcinoma - Distant metastasis - Neoadjuvant chemotherapy - Prior irradiation to the chest - Inability to read Dutch

Design outcomes

Primary

Measure	Time frame
The main study endpoint is to report the geometric uncertainty of CK-APBI in order to calculate the required PTV margin.	—

Secondary

Measure	Time frame
A first secondary endpoint will report the proportion of patients where the surgical clips, interstitial gold markers and superficial gold markers were successfully used for treatment delivery at each treatment session. Another secondary endpoint will quality the dosimetric gain of PTV margin reduction using the novel PTV margin compared to a standard expansion of 5 mm. More particularly the following metric will be evaluated: o Coverage of the CTV evaluating the V100 and V95, or proportion of the PTV that is receiving 100% or 95% of the prescribed dose o The mean dose to the ipsilateral breast tissue o The mean lung dose o The mean heart dose The third secondary endpoint will include the acute skin toxicity of CK-APBI using the NCI CTCAE 5 scale. Each breast related symptom of the scale, including oedema, erythema, pain and desquamation will be captured independently to enable future recalculation and quality assurance of the total score. .	—

Measure

Time frame

A first secondary endpoint will report the proportion of patients where the surgical clips, interstitial gold markers and superficial gold markers were successfully used for treatment delivery at each treatment session. Another secondary endpoint will quality the dosimetric gain of PTV margin reduction using the novel PTV margin compared to a standard expansion of 5 mm. More particularly the following metric will be evaluated: o Coverage of the CTV evaluating the V100 and V95, or proportion of the PTV that is receiving 100% or 95% of the prescribed dose o The mean dose to the ipsilateral breast tissue o The mean lung dose o The mean heart dose The third secondary endpoint will include the acute skin toxicity of CK-APBI using the NCI CTCAE 5 scale. Each breast related symptom of the scale, including oedema, erythema, pain and desquamation will be captured independently to enable future recalculation and quality assurance of the total score. .

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Countries

Netherlands

Outcome results