Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

accelerated hypofractionated radiotherapy (AHF-RT)

30 Gy in 5 fractions once a week for 5 weeks, followed by optional boost of 10-16 Gy

30 Gy in 5 fractions once a week for 5 weeks, followed by optional boost of 10-16 Gy

accelerated hypofractionated radiotherapy (AHF-RT)

Harriet Eldredge-Hindy, MD

The goal of this study is to explore the safety, effectiveness, quality of life, and cost effectiveness of accelerated hypofractionated radiotherapy (AHF-RT) as treatment after lumpectomy in patients with early stage breast cancer.

The traditional radiation treatment schedule for patients who have had a lumpectomy for early stage breast cancer is 15 to 30 treatments delivered once a day for 3 to 6 weeks. This treatment schedule can be inconvenient and costly for elderly, rural, uninsured, and minority patients. This study will evaluate a new radiation treatment schedule called whole-breast accelerated hypofractionated radiotherapy (AHF-RT). AHF-RT delivers higher doses of radiation in fewer treatments than traditional radiation therapy. The AHF-RT treatment course is completed with 5 radiation treatments delivered once a week for 5 weeks.

The purpose of this study is to determine if accelerated hypofractionated radiotherapy (AHF-RT) is a safe, effective, more convenient, and less costly alternative to traditional radiation that will offer the same chance of cure with no additional side effects.

Accelerated Hypofractionated Radiotherapy (AHF-RT) for the Treatment of Breast Cancer

A Phase II Study of Accelerated Hypofractionated Radiotherapy (AHF-RT) After Breast Conserving Surgery (BCS) in Medically Underserved Patients

Both invasive and non-invasive IBTRs will be considered in calculating the primary endpoint.

James Graham Brown Cancer Center

University of Louisville

Assistant Professor, M.D.

Common Terminology Criteria for Adverse Events version 3.0

accelerated hypofractionated radiotherapy (AHF-RT)

30 Gy in 5 fractions once a week for 5 weeks, followed by optional boost of 10-16 Gy

accelerated hypofractionated radiotherapy (AHF-RT): 30 Gy in 5 fractions once a week for 5 weeks, followed by optional boost of 10-16 Gy

AHF-RT

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

invasive ductal carcinoma, invasive lobular carcinoma, ductal carcinoma in situ, and other less common types of carcinoma.

Tumor Subtypes

Tumor grade was I, II, or III and was determined from surgical pathology from the time of lumpectomy. Grade 3 is worst outcome.

tumor grade

Stage was 0, IA, IB, IIA, IIB, or III and was based on AJCC 7th edition staging manual. The higher the stage the worse the outcome.

stage

Estrogen receptor status

Harriet Eldredge-Hindy

Ipsilateral Breast Tumor Recurrence (IBTR)

If chemotherapy indicated: accelerated hypofractionated radiotherapy (AHF-RT)

30 Gy in 5 fractions once a week for 5 weeks, followed by optional boost of 10-16 Gy

accelerated hypofractionated radiotherapy (AHF-RT): 30 Gy in 5 fractions once a week for 5 weeks, followed by optional boost of 10-16 Gy

AHF-RT With Chemotherapy

Overall Study

A Contura balloon catheter is placed in the lumpectomy cavity. Later that morning, accelerated partial irradiation begins.

Radiation therapy is delivered to a total dose of 34 Gy in 10 fractions bid over 5-7 days. Each day, the high dose rate iridium-192 brachytherapy treatments are separated by 6 hours. Each radiation treatment takes 15-30 minutes.

Contura catheter

Richard B Wilder, MD

Kenneth M Tokita, MD

The purpose of this study is to determine if a Contura catheter can avoid a radiation "hot spot" in the skin and improve tissue-balloon conformance in early-stage breast cancer patients undergoing accelerated partial breast irradiation.

In approximately 20% of patients who are considered for accelerated partial breast irradiation (APBI), the balloon-to-skin distance ranges from 3-6 mm. The Contura applicator has 5 source lumens. In contrast, the MammoSite catheter has a single source lumen. The ability to choose from multiple source lumens with the Contura catheter allows one to avoid a radiation "hot spot" in the skin in cases where the balloon-to-skin spacing is only 3-6 mm.

Another limitation of the MammoSite catheter is that one cannot improve on the suboptimal conformance of the balloon with the surrounding breast tissue. An air/fluid pocket next to the balloon can push breast tissue at greatest risk of harboring residual disease away from the radioactive source. With APBI, the planning target volume for plan evaluation (PTV_EVAL) is defined as the breast tissue volume bounded by uniform expansion of the balloon radius in all dimensions by 10 mm less the balloon volume. PTV_EVAL is limited to 5 mm from the skin surface and by the posterior breast tissue extent (chest wall and pectoralis muscles are excluded). The volume of an air/fluid pocket is usually 4.8% ± 1.1% (mean ± standard error) of PTV_EVAL. The Contura applicator has a vacuum lumen with 2 openings adjacent to the balloon that allow for air/fluid removal. By using the vacuum lumen on a Contura applicator, one can typically decrease the size of an air/fluid pocket by about one third. In approximately 90% of Contura patients, the volume of an air/fluid pocket around the balloon can be reduced to less than or equal to 3.0% of PTV_EVAL. In contrast, the volume of an air/fluid pocket around the balloon is less than or equal to 3.0% of PTV_EVAL in only about half of MammoSite patients. Since this study addresses intermediate-risk patients, it is particularly important that the size of an air/fluid pocket be minimized with a Contura applicator.

SenoRx, Inc. (Aliso Viejo, CA) is currently conducting a registry study of the Contura MLB applicator in the "low-risk" patient population. This "intermediate-risk" study is complimentary to the low-risk registry study. There is no overlap in patient eligibility. Intermediate-risk patients meet any of the following criteria:

1. Age 18-49 years, or
2. Estrogen receptor-negative and progesterone receptor-negative breast cancer, or
3. 1-3 involved axillary lymph nodes

Use of the Contura™ Catheter in Intermediate-Risk, Pathological Stage 0, I, or II (Up to 3.0 cm) Breast Cancer Patients

Registry Study of the Contura™ Multi-Lumen Balloon (MLB) Applicator for Accelerated Partial Breast Irradiation in Intermediate-Risk, Pathological Stage 0, I, or II (Up to 3.0 cm) Breast Cancer Patients

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Accelerated Hypofractionated Radiotherapy (AHF-RT) for the Treatment of Breast Cancer	NCT01278212	Breast Cancer	accelerated hyp...	21 Years -	University of Louisville
Use of the Contura™ Catheter in Intermediate-Risk, Pathological Stage 0, I, or II (Up to 3.0 cm) Breast Cancer Patients	NCT00882089	Breast Cancer	Contura cathete...	18 Years -	Cancer Center of Irvine
Use of the Contura™ Catheter in Intermediate-Risk, Pathological Stage 0, I, or II (Up to 3.0 cm) Breast Cancer Patients	NCT00882089	Breast Cancer	Contura cathete...	18 Years -	Cancer Center of Irvine

Spots Global Cancer Trial Database for accelerated

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

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