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Cyberknife After Breast Conservative Surgery

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Partial breast irradiation with cyberknife
Sponsored by
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 exclusion criteria were pregnancy, collagen vascular disease, aesthetic additive prostheses, severe cardiac, pulmonary and liver diseases, infectious, psychiatric illness compromising the correct acquisition of informed consent.

Sites / Locations

  • Fondazione IRCCS Istituto Neurologico C. BestaRecruiting
  • Fondazione IRCCS Istituto Nazionale dei TumoriRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cyberknife

Arm Description

APBI with cyberknife after breast conserving surgery in breast cancer

Outcomes

Primary Outcome Measures

acute and sub-acute toxicity according to NCI CTCAE Version 3.0
According to NCI CTCAE Version 3.0

Secondary Outcome Measures

Late toxicity according to NCI CTCAE Version 3.0
According to NCI CTCAE Version 3.0
Cosmesis according to NCI CTCAE Version 3.0
According to NCI CTCAE Version 3.0

Full Information

First Posted
August 4, 2016
Last Updated
September 9, 2016
Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
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1. Study Identification

Unique Protocol Identification Number
NCT02896322
Brief Title
Cyberknife After Breast Conservative Surgery
Official Title
Partial Breast Irradiation With Cyber Knife After Breast Conserving Surgery: A Pilot Study in Early Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cyberknife
Arm Type
Experimental
Arm Description
APBI with cyberknife after breast conserving surgery in breast cancer
Intervention Type
Radiation
Intervention Name(s)
Partial breast irradiation with cyberknife
Primary Outcome Measure Information:
Title
acute and sub-acute toxicity according to NCI CTCAE Version 3.0
Description
According to NCI CTCAE Version 3.0
Time Frame
within 6 months after the end of irradiation
Secondary Outcome Measure Information:
Title
Late toxicity according to NCI CTCAE Version 3.0
Description
According to NCI CTCAE Version 3.0
Time Frame
24 months after the end of irradiation
Title
Cosmesis according to NCI CTCAE Version 3.0
Description
According to NCI CTCAE Version 3.0
Time Frame
24 months after the end of irradiation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 exclusion criteria were pregnancy, collagen vascular disease, aesthetic additive prostheses, severe cardiac, pulmonary and liver diseases, infectious, psychiatric illness compromising the correct acquisition of informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roberto Agresti, MD
Phone
02-2390
Ext
2168
Email
roberto.agresti@istitutotumori.mi.it
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Fariselli, MD
Email
lfariselli@istituto-besta.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Lozza, MD
Organizational Affiliation
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione IRCCS Istituto Neurologico C. Besta
City
Milano
State/Province
Lombardy
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Fariselli, MD
Email
Laura.Fariselli@istituto-besta.it
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milan
State/Province
Lombardy
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Agresti, MD
Phone
02-2390
Ext
2168
Email
roberto.agresti@istitutotumori.mi.it
First Name & Middle Initial & Last Name & Degree
Laura Lozza, MD
Phone
02-2390
Ext
2799
Email
laura.lozza@istitutotumori.mi.it

12. IPD Sharing Statement

Citations:
PubMed Identifier
29566762
Citation
Lozza L, Fariselli L, Sandri M, Rampa M, Pinzi V, De Santis MC, Franceschini M, Trecate G, Maugeri I, Fumagalli L, Bonfantini F, Bianchi G, Pignoli E, De Martin E, Agresti R. Partial breast irradiation with CyberKnife after breast conserving surgery: a pilot study in early breast cancer. Radiat Oncol. 2018 Mar 23;13(1):49. doi: 10.1186/s13014-018-0991-4.
Results Reference
derived

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Cyberknife After Breast Conservative Surgery

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