Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Elizabeth Nichols, MD

The study is designed to assess the accuracy of patient breast reproducibly using the revised BCID. This study would provide data for target verification and quality assurance to eventually allow treatment of breast cancer patients for either a TBB or accelerated partial breast irradiation. The BCID is a low-risk device similar to immobilization devices used routinely in radiotherapy for other disease sites.

Breast conserving therapy (BCT) has become the standard of care for treating early-stage breast cancers based on six prospective randomized trials with 20 years of follow-up data (Fisher). During lumpectomy, the surgeon removes the tumor and a surrounding rim of normal tissue (margin), leaving surgical clips to help designate the resection bed. Radiation treatment is directed at the whole breast for 5 1/2 weeks and is generally followed by a 1-2 week boost directed at the lumpectomy site plus a margin of normal breast tissue. The benefit of adding the tumor bed boost, (TBB) has been shown in two studies to decrease local failures \[Romestaig; Bartelink\].

Studies have evaluated the role of radiation following lumpectomy in very select groups which have not been able to define a group who do not benefit from the addition of radiotherapy. In the group of patients who received surgery alone, 85% of the breast recurrences occurred in the tumor bed. Due to these two facts, radiotherapy directed only at the tumor bed has been evaluated. Treating this smaller tumor volume has allowed higher doses of radiation to be delivered safely shortening the treatment course from 6-7 weeks to one week.

Breast Cup Immobilization Device II (GCC 1047)

Geometric Reproducibility of the Lumpectomy Cavity Using a Breast Cup Immobilization Device II

Complete clinical feasibility of using a breast cup immobilization device for prone breast irradiation in terms of both geometric and dosimetric accuracy. Measurements were able to be completed on 25 participants through treatment planning CT scans.

Assess patient comfort while wearing the breast cup immobilization device. Patients provided questionnaire to rate comfort level (discomfort was ranked from 0 (no pain) to 5 (very painful).

Candidates being assessed based on their breast size, tumor or tumor bed size, tumor or tumor bed location and normal tissue proximity by evaluating GammaPod treatment plans developed using the acquired CT images. Through images, patients were evaluated for their ability to meet the requirements for GammaPod treatment based off the factors mentioned previously.

University of Maryland, Baltimore

Principal Investigator

Breastcup

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

Elizabeth M. Nichols, MD

Analysis was done through imaging assessment. Completed on all 25 patients.

Breast Cup Immobilization Device II (GCC 1047) Feasibility

Assess patient comfort while wearing the breast cup immobilization device and evaluate mock treatment plans for patients using the acquired CT images.

Breast Cup Immobilization Device II (GCC 1047) Comfort

Number of Participants That Were Favorable Candidates for Receiving GammaPod Treatment

Overall Study

Symptoms and General Pathology

Recurrence

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

Jean-Michel HANNOUN LEVI, Phd

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).

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.

Single Fraction Elderly Breast Irradiation (SiFEBI)

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

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.

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

Centre Antoine Lacassagne

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

Age, Continuous

France

Region of Enrollment

Professeur JM Hannoun-Levi

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)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Breast Cup Immobilization Device II (GCC 1047)	NCT01704547	Breast Cancer		18 Years -	University of Maryland, Baltimore
Single Fraction Elderly Breast Irradiation (SiFEBI)	NCT01727011	Breast Cancer	IPAS	70 Years -	Centre Antoine Lacassagne

Spots Global Cancer Trial Database for breast irradiation