Cyberknife After Breast Conservative Surgery
Partial Breast Irradiation With Cyber Knife After Breast Conserving Surgery: A Pilot Study in Early Breast Cancer
1 other identifier
interventional
80
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable breast-cancer
Started Jun 2013
Longer than P75 for not_applicable breast-cancer
2 active sites
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
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedFirst Posted
Study publicly available on registry
September 12, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedSeptember 12, 2016
September 1, 2016
3.3 years
August 4, 2016
September 9, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Late toxicity according to NCI CTCAE Version 3.0
24 months after the end of irradiation
Cosmesis according to NCI CTCAE Version 3.0
24 months after the end of irradiation
Study Arms (1)
Cyberknife
EXPERIMENTALAPBI with cyberknife after breast conserving surgery in breast cancer
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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);
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardy, 20133, Italy
Fondazione IRCCS Istituto Neurologico C. Besta
Milan, Lombardy, 20133, Italy
Related Publications (1)
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.
PMID: 29566762DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laura Lozza, MD
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2016
First Posted
September 12, 2016
Study Start
June 1, 2013
Primary Completion
September 1, 2016
Study Completion
June 1, 2018
Last Updated
September 12, 2016
Record last verified: 2016-09