Cyberknife After Breast Conservative Surgery

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

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Radiation: Partial breast irradiation with cyberknife

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lombardy
    • Milan, Lombardy, Italy, 20133
      • Recruiting
      • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Contact: Roberto Agresti, MD; Phone Number: 2168 02-2390; Email: roberto.agresti@istitutotumori.mi.it
      • Contact: Laura Lozza, MD; Phone Number: 2799 02-2390; Email: laura.lozza@istitutotumori.mi.it
    • Milano, Lombardy, Italy, 20133
      • Recruiting
      • Fondazione IRCCS Istituto Neurologico C. Besta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cyberknife; APBI with cyberknife after breast conserving surgery in breast cancer	Radiation: Partial breast irradiation with cyberknife

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
acute and sub-acute toxicity according to NCI CTCAE Version 3.0	According to NCI CTCAE Version 3.0	within 6 months after the end of irradiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Late toxicity according to NCI CTCAE Version 3.0	According to NCI CTCAE Version 3.0	24 months after the end of irradiation
Cosmesis according to NCI CTCAE Version 3.0	According to NCI CTCAE Version 3.0	24 months after the end of irradiation

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Investigators: Principal Investigator: Laura Lozza, MD, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): September 1, 2016
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: August 4, 2016
• First Submitted That Met QC Criteria: September 9, 2016
• First Posted (Estimate): September 12, 2016

Study Record Updates

• Last Update Posted (Estimate): September 12, 2016
• Last Update Submitted That Met QC Criteria: September 9, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: INT 109/12