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Cyberknife After Breast Conservative Surgery

Partial Breast Irradiation With Cyber Knife After Breast Conserving Surgery: A Pilot Study in Early Breast Cancer

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02896322
Enrollment
80
Registered
2016-09-12
Start date
2013-06-30
Completion date
2018-06-30
Last updated
2016-09-12

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

Conditions

Breast Cancer

Brief summary

Accelerated partial breast irradiation with CyberKnife (CK-APBI) is a promising innovative approach for early breast cancer after conservative surgery, for addressing the need of a radiotherapy target only to the surgical cavity in selected patients, exceeding the limits of other PBI/APBI.

Detailed description

The large majority of local recurrences in breast cancer after breast conserving treatment are close to the original tumor site. This evidence suggested to restrict the radiotherapy target to the surgical cavity in selected patients. Consequently, shorter fractionation strategies focused only on tumor bed with a small cuff of surrounding subclinical disease, i.e. accelerated partial breast irradiation (APBI), were developed. Stereotactic radiotherapy was thought, consisting of a short course of intense treatment focused on the target tissue. There is very little experience with CiberKnife for early breast cancer until now. This study is a prospective non-randomized study designed to assess the acute, sub-acute, late toxicity, cosmesis and globally the feasibility of CyberKnife (CK-APBI). From June 2013 to June 2018 we are going to enroll 80 patients considered eligible for the present study. All patients will be followed for at least 2 years. A first enrollment of 20-25 patients is scheduled as first assessment. Breast magnetic resonance imaging (MRI) will be aided to mammography and ultrasound examination for confirming the best selection of patients. For the assessment of acute toxicity, cosmetic results by three different observers (physician, patient, external observer), medium term and late toxicity, patients were evaluated and the results recorded immediately before and after radiotherapy, then after 1 month, three, six, nine, and twelve, and twenty-four months. The toxicity will be correlated to the main radiotherapy treatment dosimetry and delivery recorded.

Interventions

RADIATIONPartial breast irradiation with cyberknife

Sponsors

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients were ≥45 years of age with stage I-IIA histologically confirmed breast carcinoma, with tumor-free (at least 2 mm or more) inked histologic margins at surgical resection.

Exclusion criteria

* Invasive lobular or multicentric carcinoma; * Extensive associated non-invasive ductal carcinoma (synchronous or previous); peritumoral vascular invasion (\>3 vessels); * BRCA mutation carriers, * \>4 involved axillary lymph nodes, * Distant metastasis, * Non-epithelial malignancies of the breast, * Synchronous contralateral invasive carcinoma, * Paget disease, * History of previous malignancy (except non-melanoma skin cancers and in situ oral cavity and cervix carcinoma); * Further

Design outcomes

Primary

MeasureTime frameDescription
acute and sub-acute toxicity according to NCI CTCAE Version 3.0within 6 months after the end of irradiationAccording to NCI CTCAE Version 3.0

Secondary

MeasureTime frameDescription
Late toxicity according to NCI CTCAE Version 3.024 months after the end of irradiationAccording to NCI CTCAE Version 3.0
Cosmesis according to NCI CTCAE Version 3.024 months after the end of irradiationAccording to NCI CTCAE Version 3.0

Countries

Italy

Contacts

Primary ContactRoberto Agresti, MD
roberto.agresti@istitutotumori.mi.it02-2390
Backup ContactLaura Fariselli, MD
lfariselli@istituto-besta.it

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026