Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

IGRT for prone partial breast irradiation (PBI): All patients will be treated prone with 6 Gy/fraction delivered in 5 fractions over a 1-week period for a total dose of 30 Gy.

IGRT for prone partial breast irradiation (PBI): All patients will be treated prone with 6 Gy/fraction delivered in 5 fractions over a 1-week period for a total dose of 30 Gy. Simulation and treatment will be started within 50 days from surgery in order to maximize the chances of optimal lumpectomy cavity visualization on the planning and cone beam CT scans. All patients will be followed monthly for the first 90 days then q3 months for the first year, then yearly for the next 10 years.

IGRT for prone partial breast irradiation (PBI)

Carmen Perez, M.D.

Partial breast irradiation (PBI) is becoming a new paradigm for breast cancer radiation.\[1\] No type I or II evidence is currently available to demonstrate equivalence to standard whole breast radiotherapy, and a prospective randomized trial jointly sponsored by NSABP and RTOG (NSABP B-39 and RTOG 0413) is currently accruing patients, comparing whole breast radiotherapy to PBI, either by brachytherapy or external beam techniques (EB). Until the results of this or similar trials are available, PBI remains a research domain, and it should be offered to patients only in the context of a clinical experimental protocol.

Despite the fact that less extensive experience than that of brachytherapy is available, PBI delivery through an external-beam has many advantages. First of all, it is likely to be more acceptable to the patient since it is non-invasive and it does not require a surgical procedure or anesthesia. Moreover, since it is delivered after surgery, the pathological analysis of the segmental mastectomy specimen is available to inform the selection of the best candidates. In addition, EB-PBI is likely to become more widely reproducible, since it does not rely on the experience and skills of the radiation oncologist performing the brachytherapy implant. Besides, once the technique is established, it can be widely applied at any facility provided with a linear accelerator, without the risk presented by some brachytherapy approaches that can not be completed because of the unfavorable interplay of patient's anatomy with the technical limitations of the applicator. Finally, in terms of health care economics, an external beam approach spares the costs of an extra surgical procedure and that of several days of hospitalization (in the case of LDR brachytherapy).

Image Guided Radiotherapy (IGRT) for Prone Partial Breast Irradiation

Image Guided Radiotherapy (IGRT) for Prone Partial Breast Irradiation (PBI)

Apply IGRT to PBI as part of breast preservation in post-menopausal women with T1 breast cancers and acquire preliminary data on the role of this tool to assure correct targeting.

Measure local recurrence within the field of conformal radiation as well as local recurrence outside the field

Assess the feasibility of an accelerated dose fractionation (600 cGy x 5) when given over five consecutive day by measuring the acute and late radiation toxicity

Prospectively determine if genetic factors can be identified which may predispose a patient to the development of post-treatment radiation fibrosis

NYU Langone Health

Prone partial breast irradiation of 6 Gy x 5 over 5 days, on five consecutive days

Prone partial breast irradiation of 8 Gy x 3 over 5 days, every other day

Patients will receive 3D-Conformal or Intensity Modulated Radiation Therapy (IMRT) of 6 Gy x 5, over 5 consecutive days

PBI Radiotherapy 6 Gy

Patients will receive 3D-Conformal or Intensity Modulated Radiation Therapy (IMRT) of 8 Gy x 3, over 5 days, every other day

PBI Radiotherapy 8 Gy

Naamit Gerber, MD

The purpose of this study is to test whether a radiotherapy regimen of 8 GY x 3 days over 5 days (every other day) is as safe (well-tolerated) and effective as 6 Gy x 5 over five consecutive days

Despite the fact that less extensive experience than that of brachytherapy is available, PBI delivery through an external-beam has many advantages. First of all, it is likely to be more acceptable to the patient since it is non-invasive and it does not require a surgical procedure or anesthesia. Moreover, since it is delivered after surgery, the pathological analysis of the segmental mastectomy specimen is available to inform the selection of the best candidates. In addition, EB-PBI is likely to become more widely reproducible, since it does not rely on the experience and skills of the radiation oncologist performing the brachytherapy implant. Besides, once the technique is established, it can be widely applied at any facility provided with a linear accelerator, without the risk presented by some brachytherapy approaches that can not be completed because of the unfavorable interplay of patient's anatomy with the technical limitations of the applicator.

The women in this study will receive either 5 or 3 radiation fractions to the tumor bed. We have chosen to study T1 post menopausal women because in this subset: 1) the tumor is small enough to be treated by partial breast radiation 2) the odds of having multicentric disease are low, making it ethical to avoid whole breast irradiation, 3) the most benefit from reducing the radiation schedule from 5 to 3 could be expected.

All patients will receive either 8 Gy x 3 over 5 days, every other day or 6 Gy x 5 over 5 days, on five consecutive days

Prone Partial Breast Irradiation (PBI): a Prospective Randomized Trial

Prone Partial Breast Irradiation (PBI): A Prospective Randomized Trial Comparing Five Versus Three Fractions

We will measure non-inferiority to the current 1% local recurrence rate at 5 years

We will measure the non-inferiority to the 5 year fibrosis rate of 24-36%

At the time of local recurrence, patients will undergo disease assessment and will be further grouped as:

Isolated local/regional recurrence Concomitant local/regional and distant recurrence

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Image Guided Radiotherapy (IGRT) for Prone Partial Breast Irradiation	NCT02272400	Breast Cancer	IGRT for prone ...	18 Years - 65 Years	NYU Langone Health
Prone Partial Breast Irradiation (PBI): a Prospective Randomized Trial	NCT02276885	Breast Cancer	PBI Radiotherap... PBI Radiotherap...	50 Years - 90 Years	NYU Langone Health
Prone Partial Breast Irradiation (PBI): a Prospective Randomized Trial	NCT02276885	Breast Cancer	PBI Radiotherap... PBI Radiotherap...	50 Years - 90 Years	NYU Langone Health

Spots Global Cancer Trial Database for pbi

Every month we try and update this database with for pbi cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pbi

Every month we try and update this database with for pbi cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pbi cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.