Single Fraction Elderly Breast Irradiation (SiFEBI)

NCT01727011 | Completed Results DMC

• 2 other identifiers: 2012/09 - SIFEBI2012-A00745-38
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer

Keywords

Single fraction; Elderly; Breast Irradiation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Evaluation of the Quality of Life

  180 days

Study Arms (1)

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

Radiation: IPAS

Interventions

IPAS RADIATION

Also known as: irradiation and partial accelerated breast brachytherapy

IPAS

Eligibility Criteria

• Age: 70 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Antoine Lacassagne: lead

Study Sites (1)

Centre Antoine Lacassagne

Nice, 06189, France

Location

Related Publications (1)

• 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.

  PMID: 29254856 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Results Point of Contact

• Title: Professeur JM Hannoun-Levi
• Organization: Centre Antoine Lacassagne

jean-michel.hannoun-levi@nice.unicancer.fr

04.92.03.12.60

Study Officials

• Jean-Michel HANNOUN LEVI, Phd

  Centre Antoine Lacassagne

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: November 12, 2012
• First Posted: November 15, 2012
• Study Start: November 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: November 1, 2015
• Last Updated: December 17, 2021
• Results First Posted: December 17, 2021

Record last verified: 2021-11

Locations

FR (1)