Breast CancerSIFEBINCT01727011
Single Fraction Elderly Breast Irradiation (SiFEBI)
A study testing IPAS in people with Breast Cancer, run by Centre Antoine Lacassagne at 1 site in France.
Trial summary
Irradiation and Accelerated Partial Breast (IPAS) to this day remains a therapeutic concept whose validity is being assessed on its non-inferiority in terms of local control compared to whole breast irradiation. Read more about this study
- Who is it for?
- Ages 70 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- IPAS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2012to Nov 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Patient WITHinvasive breast cancer histologically proved: ductal, lobular, medullary, papillary, tubular or colloid:
- All grades histo-prognostic
- pT1 tumor size (<20 mm),
- healthy Margins surgical
- unifocal lesion
- Any hormone receptor,
Show all 15Show fewer
- Any Her2 status,
- No lymph node (sentinel lymphadenectomy or) or micrometastases (pN0, pN1mic)
- Age greater than or equal to 70 years
- Score Balducci I or II,
- Karnofsky index greater than or equal to 70%
- Time between lumpectomy and radiation less than 2 weeks
- Implementation of clips in the tumor bed intraoperatively,
- Patient having taken note of the information note and who signed the informed consent
- Patient receiving social security coverage.
Who cannot join
- Lobular carcinoma in situ or pure ductal carcinoma in situ or non-epithelial tumor type sarcoma or lymphoma,
- Component extensive ductal in situ associated
- Peritumoral lymphatic emboli,
- Distance Metastasis
- Inflammatory Breast Cancer,
- Multifocal tumor (covering a total distance inter-end of 40 mm or more)
Show all 14Show fewer
- Previous treatment for this tumor including breast radiotherapy and / or chemotherapy neoadjuvant or adjuvant
- History of plastic surgery breast
- Unknown or safety margins positive for invasive carcinoma
- Absence of clips in the tumor bed,
- Time between lumpectomy and radiation greater than or equal to 2 weeks
- Active infection or other serious comorbidity that could prevent the patient receiving the treatment,
- History of cancer other than a basal cell skin or carcinoma in situ of the cervix or other cancer in complete remission for more than 5 years
- Psychiatric illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I-II Trial Evaluating the Toxicity of Early Breast Partial Irradiation in Patients Aged at Least of 70 Years With Breast Cancer at Low Risk of Local Recurrence
Irradiation and Accelerated Partial Breast (IPAS) to this day remains a therapeutic concept whose validity is being assessed on its non-inferiority in terms of local control compared to whole breast irradiation. At least eight phase III trials attempting to answer this question and thus provide a sufficient level of evidence to make this concept a new standard of care for sub-groups of patients well defined (1).
However, without waiting for the final results of these randomized trials (which will not be fully valid with a drop of at least ten years), the American societies (ASTRO) and European (ESTRO) radiotherapy have all two proposed classification (very similar) into 3 groups according to the risk to the patient in terms of local recurrence after IPAS. And are defined by the ESTRO:
Read more
- The low-risk group ("suitable" for ASTRO)
- The intermediate-risk group ("cautionary" in ASTRO)
- The high-risk group ("not suitable" for ASTRO) (2.3). Therefore, it is possible to propose to a patient a randomized clinical tria IPAS, to subject it belongs to the group "low risk." The results of phase II trials as a long-term analysis of the matched team of William Beaumont Hospital (4) and the phase III trial using intra-operative radiation photons in low energy X whose results were recently published (5) confirm the value of this new therapeutic concept for post-operative breast cancer at low risk of local recurrence.
In France, the therapists were quickly directed to a sub-population for which the IPAS could represent a real improvement in the therapeutic management in significantly reducing the number of irradiation sessions of thirty in 6 weeks 5 days at 10 in a single view (6). Several French phase II trials were started specifically targeting the female population aged using a balloon catheter (MammoSite ®) (7) or by intra-operative radiation électronthérapie (8). The results of the test using the GERICO-03 brachytherapy with high dose rate (promoter: FNCLCC, National Federation of Anti Cancer Centres , recently merged into Group Health Cooperation entitled UNICANCER) are currently submitted to Journal Green Radiotherapy (Radiotherapy and Oncology from 09/11/11) (9).
On a technical level, two main approaches are used (10):
- Irradiation intraoperative electron or low-energy photons,
- Radiation after surgery The advantage of intraoperative irradiation is the optimal reduction of total processing time radio-surgery because the patient is irradiated during the lumpectomy. However, 15-20% of these patients receive partial breast irradiation, as histo-prognostic criteria provided in the histologically final report, confirm the non-adapted indication of IPAS (5).
In contrast, the post-operative IPAS can treat only patients meeting all criteria for IPAS but treatment-related travel are about 5 treatments for bi-fractionated (2 sessions per days separated by at least 6 hours).
Read the detailed description
Single dose intraoperative issued by electrontherapy or low energy photons (50 Kv) is 21 Gy (5.11). However, these doses reported in the irradiated volume are not equivalent. Indeed, with electrontherapy, it is a complete volume of mammary parenchyma that is irradiated, whereas with low energy photon therapy (X 50 KV) is a "shell" of 5 mm thick which is treated knowing that to 10 mm from the surface of the sphere of treatment, the gland received only 50% of the dose initially prescribed. On interstitial brachytherapy with high dose rate, it has a dose escalation due to intrinsic volumes located within the irradiated area that will receive a higher dose than prescribed (12). It is this variation in dose within the target volume which can be efficiency, but also which can induce the toxicity of interstitial brachytherapy. The linear quadratic model to calculate the biological equivalence of 2 Gy irradiation scheme most often hypofractionned, is theoretically applicable for doses per fraction less than 8 Gy. Nevertheless, the authors using the IPAS intra-operative (electrons, photons) apply this method of calculation for doses of 21 Gy in one fraction.
In our study, we propose to treat these patients with a total dose of 16 Gy in one fraction. This dose is calculated taking into account a report alpha/beta for the breast, on the order of 3.4 Gy for late toxicity and 4.6 Gy for local control (13). Applying the linear-quadratic model with alpha/beta for the breast of 4, 16 Gy in one fraction is calculated as radio-biologically equivalent to 53 Gy in conventional fractionation (14,15). Biological Equivalence of this dose is between the dose in the protocols IPAS intraoperative electron or X-ray photons of 50 kV (21 Gy in one fraction, 87 Gy EQD2 alpha/beta 4.6) (5.8) and the post-operative irradiation of 34-38 Gy in 10 fractions, 5 days (42 Gy EQD2 alpha/beta 4.6.
- Conditions
- Breast Cancer
- Being tested
- IPAS
- Keywords
- Single fraction, Elderly, Breast Irradiation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPASRadiation
Also called irradiation and partial accelerated breast brachytherapy
| Study group | Role | What they receive |
|---|---|---|
| IPAS | Experimental | Once the patient recorded in the trial, and after completion of a post-implant dosimetry scanner to analyze the dose distribution within the target volume and organs at risk, the patient is treated by irradiation and partial accelerated breast brachytherapy using high dose rate, delivering a total dose of 16 Gy in one fraction Receives: Radiation: IPAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Acute Toxicity Within 180 Days of IPAS Mono Split Postoperatively in Patients Aged at Least of 70 Years With Breast Cancer at Low Risk of Local Recurrence (Low Risk Group of ESTRO IPAS Classification ESTRO)
Rate of acute toxicity evaluated by a clinical examination, in consultation with the radiotherapist to 30, 90 days and 180 days.
Common Toxicity Criteria classification for Adverse Events (CTCAE) in its fourth version is used.
Measured: 180 days
Secondary outcomes (1)
Evaluation of the Quality of Life
Analysis of the impact on self assessment by onco-geriatric aesthetic result evaluation Dosimetric data analysis in order to propose dose constraints for future inverse planning
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionJun 2014
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Antoine Lacassagne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Michel HANNOUN LEVI, Phd, Principal investigator, Centre Antoine Lacassagne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01727011
- Sponsor's protocol ID
- 2012/09 - SIFEBI
- Other IDs
- 2012-A00745-38
- Acronym
- SIFEBI
- Status last verified
- Nov 2021
- First submitted
- 12 Nov 2012
- Last updated
- 17 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hannoun-Levi JM, Cham Kee DL, Gal J, Schiappa R, Hannoun A, Gautier M, Boulahssass R, Peyrottes I, Barranger E, Ferrero JM, Chand ME, Doyen J. Accelerated partial breast irradiation for suitable elderly women using a single fraction of multicatheter interstitial high-dose-rate brachytherapy: Early results of the Single-Fraction Elderly Breast Irradiation (SiFEBI) Phase I/II trial. Brachytherapy. 2018 Mar-Apr;17(2):407-414. doi: 10.1016/j.brachy.2017.11.008. Epub 2017 Dec 15.
PubMed 29254856
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I-II Trial Evaluating the Toxicity of Early Breast Partial Irradiation in Patients Aged at Least of 70 Years With Breast Cancer at Low Risk of Local Recurrence
- ClinicalTrials.gov ID
- NCT01727011
- Acronym / sponsor ID
- SIFEBI / 2012/09 - SIFEBI
- Conditions
- Breast Cancer
- Keywords
- Single fraction, Elderly, Breast Irradiation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Centre Antoine LacassagneUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 15 Nov 2012 (estimated)
- Results
- Posted 17 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Irradiation and Accelerated Partial Breast (IPAS) to this day remains a therapeutic concept whose validity is being assessed on its non-inferiority in terms of local control compared to whole breast irradiation. At least eight phase III trials attempting to answer this question and thus provide a sufficient level of evidence to make this concept a new standard of care for sub-groups of patients well defined (1).
However, without waiting for the final results of these randomized trials (which will not be fully valid with a drop of at least ten years), the American societies (ASTRO) and European (ESTRO) radiotherapy have all two proposed classification (very similar) into 3 groups according to the risk to the patient in terms of local recurrence after IPAS. And are defined by the ESTRO:
- The low-risk group ("suitable" for ASTRO)
- The intermediate-risk group ("cautionary" in ASTRO)
- The high-risk group ("not suitable" for ASTRO) (2.3). Therefore, it is possible to propose to a patient a randomized clinical tria IPAS, to subject it belongs to the group "low risk." The results of phase II trials as a long-term analysis of the matched team of William Beaumont Hospital (4) and the phase III trial using intra-operative radiation photons in low energy X whose results were recently published (5) confirm the value of this new therapeutic concept for post-operative breast cancer at low risk of local recurrence.
In France, the therapists were quickly directed to a sub-population for which the IPAS could represent a real improvement in the therapeutic management in significantly reducing the number of irradiation sessions of thirty in 6 weeks 5 days at 10 in a single view (6). Several French phase II trials were started specifically targeting the female population aged using a balloon catheter (MammoSite ®) (7) or by intra-operative radiation électronthérapie (8). The results of the test using the GERICO-03 brachytherapy with high dose rate (promoter: FNCLCC, National Federation of Anti Cancer Centres , recently merged into Group Health Cooperation entitled UNICANCER) are currently submitted to Journal Green Radiotherapy (Radiotherapy and Oncology from 09/11/11) (9).
On a technical level, two main approaches are used (10):
- Irradiation intraoperative electron or low-energy photons,
- Radiation after surgery The advantage of intraoperative irradiation is the optimal reduction of total processing time radio-surgery because the patient is irradiated during the lumpectomy. However, 15-20% of these patients receive partial breast irradiation, as histo-prognostic criteria provided in the histologically final report, confirm the non-adapted indication of IPAS (5).
In contrast, the post-operative IPAS can treat only patients meeting all criteria for IPAS but treatment-related travel are about 5 treatments for bi-fractionated (2 sessions per days separated by at least 6 hours).
Detailed description
Single dose intraoperative issued by electrontherapy or low energy photons (50 Kv) is 21 Gy (5.11). However, these doses reported in the irradiated volume are not equivalent. Indeed, with electrontherapy, it is a complete volume of mammary parenchyma that is irradiated, whereas with low energy photon therapy (X 50 KV) is a "shell" of 5 mm thick which is treated knowing that to 10 mm from the surface of the sphere of treatment, the gland received only 50% of the dose initially prescribed. On interstitial brachytherapy with high dose rate, it has a dose escalation due to intrinsic volumes located within the irradiated area that will receive a higher dose than prescribed (12). It is this variation in dose within the target volume which can be efficiency, but also which can induce the toxicity of interstitial brachytherapy. The linear quadratic model to calculate the biological equivalence of 2 Gy irradiation scheme most often hypofractionned, is theoretically applicable for doses per fraction less than 8 Gy. Nevertheless, the authors using the IPAS intra-operative (electrons, photons) apply this method of calculation for doses of 21 Gy in one fraction.
In our study, we propose to treat these patients with a total dose of 16 Gy in one fraction. This dose is calculated taking into account a report alpha/beta for the breast, on the order of 3.4 Gy for late toxicity and 4.6 Gy for local control (13). Applying the linear-quadratic model with alpha/beta for the breast of 4, 16 Gy in one fraction is calculated as radio-biologically equivalent to 53 Gy in conventional fractionation (14,15). Biological Equivalence of this dose is between the dose in the protocols IPAS intraoperative electron or X-ray photons of 50 kV (21 Gy in one fraction, 87 Gy EQD2 alpha/beta 4.6) (5.8) and the post-operative irradiation of 34-38 Gy in 10 fractions, 5 days (42 Gy EQD2 alpha/beta 4.6.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IPAS | Experimental | Radiation: IPASOnce the patient recorded in the trial, and after completion of a post-implant dosimetry scanner to analyze the dose distribution within the target volume and organs at risk, the patient is treated by irradiation and partial accelerated breast brachytherapy using high dose rate, delivering a total dose of 16 Gy in one fraction |
Who may qualify
- Ages
- 70 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (15 listed)
- Patient WITHinvasive breast cancer histologically proved: ductal, lobular, medullary, papillary, tubular or colloid:
- Age greater than or equal to 70 years
- Score Balducci I or II,
- Karnofsky index greater than or equal to 70%
- Time between lumpectomy and radiation less than 2 weeks
Key exclusion criteria (14 listed)
- Lobular carcinoma in situ or pure ductal carcinoma in situ or non-epithelial tumor type sarcoma or lymphoma,
- Component extensive ductal in situ associated
- Peritumoral lymphatic emboli,
- Distance Metastasis
- Inflammatory Breast Cancer,
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 |
|---|---|---|
| IPASAlso: irradiation and partial accelerated breast brachytherapy | Radiation | IPAS |
Primary outcome
Rate of Acute Toxicity Within 180 Days of IPAS Mono Split Postoperatively in Patients Aged at Least of 70 Years With Breast Cancer at Low Risk of Local Recurrence (Low Risk Group of ESTRO IPAS Classification ESTRO)
Time frame: 180 days
Rate of acute toxicity evaluated by a clinical examination, in consultation with the radiotherapist to 30, 90 days and 180 days. Common Toxicity Criteria classification for Adverse Events (CTCAE) in its fourth version is used.
1 secondary outcome
Evaluation of the Quality of Life
Time frame: 180 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29254856Hannoun-Levi JM, Cham Kee DL, Gal J, Schiappa R, Hannoun A, Gautier M, Boulahssass R, Peyrottes I, Barranger E, Ferrero JM, Chand ME, Doyen J. Accelerated partial breast irradiation for suitable elderly women using a single fraction of multicatheter interstitial high-dose-rate brachytherapy: Early results of the Single-Fraction Elderly Breast Irradiation (SiFEBI) Phase I/II trial. Brachytherapy. 2018 Mar-Apr;17(2):407-414. doi: 10.1016/j.brachy.2017.11.008. Epub 2017 Dec 15.
- Related InfoLink provided by the sponsor.
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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.
Jean-Michel HANNOUN LEVI, Phd principal investigator
Centre Antoine Lacassagne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPAS in people with Breast Cancer, run by Centre Antoine Lacassagne at 1 site in France.
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 15 inclusion and 14 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: finished, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Yes. Results are posted in the registry (first posted 17 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Acute Toxicity Within 180 Days of IPAS Mono Split Postoperatively in Patients Aged at Least of 70 Years With Breast Cancer at Low Risk of Local Recurrence (Low Risk Group of ESTRO IPAS Classification ESTRO) (time frame: 180 days). 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 NCT01727011, 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 17 Dec 2021.