Breast CancerNCT02896322
Cyberknife After Breast Conservative Surgery
A study testing Partial breast irradiation with cyberknife in people with Breast Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Partial breast irradiation with cyberknife
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesItaly
- Study dates
- Jun 2013to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
2 sites in 1 country.
Laura Fariselli, MD contact
Italy2 sites, 2 recruiting
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardy, 20133
Roberto Agresti, MD, 02-2390 ext. 2168, roberto.agresti@istitutotumori.mi.it
Laura Lozza, MD, 02-2390 ext. 2799, laura.lozza@istitutotumori.mi.it
- Recruiting
Fondazione IRCCS Istituto Neurologico C. Besta
Milan, Lombardy, 20133
Laura Fariselli, MD, Laura.Fariselli@istituto-besta.it
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Partial breast irradiation with cyberknife
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial breast irradiation with cyberknifeRadiation
| Study group | Role | What they receive |
|---|---|---|
| Cyberknife | Experimental | APBI with cyberknife after breast conserving surgery in breast cancer Receives: Radiation: Partial breast irradiation with cyberknife |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute and sub-acute toxicity according to NCI CTCAE Version 3.0
According to NCI CTCAE Version 3.0
Measured: within 6 months after the end of irradiation
Secondary outcomes (2)
Late toxicity according to NCI CTCAE Version 3.0
According to NCI CTCAE Version 3.0
Measured: 24 months after the end of irradiation
Cosmesis according to NCI CTCAE Version 3.0
According to NCI CTCAE Version 3.0
Measured: 24 months after the end of irradiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study startJun 2013
- Primary completionSep 2016
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Lozza, MD, Principal investigator, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896322
- Sponsor's protocol ID
- INT 109/12
- Status last verified
- Sep 2016
- First submitted
- 4 Aug 2016
- Last updated
- 12 Sep 2016
- Results posted
- No
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.
PubMed 29566762
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partial Breast Irradiation With Cyber Knife After Breast Conserving Surgery: A Pilot Study in Early Breast Cancer
- ClinicalTrials.gov ID
- NCT02896322
- Acronym / sponsor ID
- INT 109/12
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Jun 2018 (estimated)
- First posted
- 12 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cyberknife | Experimental | Radiation: Partial breast irradiation with cyberknifeAPBI with cyberknife after breast conserving surgery in breast cancer |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partial breast irradiation with cyberknife | Radiation | Cyberknife |
Primary outcome
acute and sub-acute toxicity according to NCI CTCAE Version 3.0
Time frame: within 6 months after the end of irradiation
According to NCI CTCAE Version 3.0
2 secondary outcomes
Late toxicity according to NCI CTCAE Version 3.0
Time frame: 24 months after the end of irradiation
Cosmesis according to NCI CTCAE Version 3.0
Time frame: 24 months after the end of irradiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2016.
- Derived from this study: PubMed 29566762Lozza 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Fariselli, MD contact
Laura Lozza, MD principal investigator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partial breast irradiation with cyberknife in people with Breast Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roberto Agresti, MD (02-2390 ext. 2168, roberto.agresti@istitutotumori.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acute and sub-acute toxicity according to NCI CTCAE Version 3.0 (time frame: within 6 months after the end of irradiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02896322, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2016.