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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A00745-38 | Registry Identifier | 2012-A00745-38 |
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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:
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):
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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IPAS | Radiation |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 180 days |
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Inclusion Criteria:
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
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Michel HANNOUN LEVI, Phd | Centre Antoine Lacassagne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Antoine Lacassagne | Nice | 06189 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29254856 | Derived | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Irradiation and Accelerated Partial Breast (IPAS) | 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 IPAS |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IPAS | 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 IPAS |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | percentage of participants | 180 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IPAS | 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 IPAS |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| left breast painful inflammatory syndroma | Reproductive system and breast disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| BREAST FIBROSIS | Reproductive system and breast disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professeur JM Hannoun-Levi | Centre Antoine Lacassagne | 04.92.03.12.60 | jean-michel.hannoun-levi@nice.unicancer.fr |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D011827 | Radiation |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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 | Not Posted | Nov 2021 | 180 days | Participants |
| 3 |
| 26 |
| 26 |
| 26 |
| tacchycardia | Cardiac disorders | Systematic Assessment |
|
| right breast haematoma | Reproductive system and breast disorders | Systematic Assessment |
|
| INJECTION SITE INFLAMMATION | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| BREAST HAEMATOMA | Reproductive system and breast disorders | Systematic Assessment |
|
| BREAST PAIN | Reproductive system and breast disorders | Systematic Assessment |
|
| SKIN HYPERPIGMENTATION | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| RADIATION SKIN INJURY | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |