Single Fraction Elderly Breast Irradiation (SiFEBI) (SIFEBI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01727011
Recruitment Status : Completed
First Posted : November 15, 2012
Last Update Posted : November 16, 2015
Information provided by (Responsible Party):
Centre Antoine Lacassagne

Brief 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. 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).

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: IPAS Phase 1 Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : November 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: 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
Radiation: IPAS
Other Name: irradiation and partial accelerated breast brachytherapy

Primary Outcome Measures :
  1. Evaluate the early toxicity (less than 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: June 2014 ]

    Rate of acute toxicity evaluated bu 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.

Secondary Outcome Measures :
  1. Evaluation of the quality of life [ Time Frame: June 2014 ]
    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

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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,
    • 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.

Exclusion Criteria:

  • 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)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01727011

Centre Antoine Lacassagne
Nice, France, 06189
Sponsors and Collaborators
Centre Antoine Lacassagne
Principal Investigator: Jean-Michel HANNOUN LEVI, Phd Centre Antoine Lacassagne

Additional Information:
Responsible Party: Centre Antoine Lacassagne Identifier: NCT01727011     History of Changes
Other Study ID Numbers: 2012/09 - SIFEBI
2012-A00745-38 ( Registry Identifier: 2012-A00745-38 )
First Posted: November 15, 2012    Key Record Dates
Last Update Posted: November 16, 2015
Last Verified: November 2015

Keywords provided by Centre Antoine Lacassagne:
Single fraction
Breast Irradiation

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases