Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

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	Link
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 prone

Every month we try and update this database with for prone 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 prone

Every month we try and update this database with for prone 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 prone 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.