Know Cancer

or
forgot password

Spect Analysis of Cardiac Perfusion Changes After Whole Breast/Chest Wall Radiation Therapy With Active Breathing Coordinator


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Breast Neoplasms, Carcinoma, Ductal, Adenocarcinoma

Thank you

Trial Information

Spect Analysis of Cardiac Perfusion Changes After Whole Breast/Chest Wall Radiation Therapy With Active Breathing Coordinator


50 left sided breast cancer patients will be randomized to receive breast/chest wall
irradiation with or without ABC. Patients will receive radiation therapy at a dose of
180-200 cGy per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional
radiation to the lumpectomy bed or mastectomy scar is at the discretion of the treating
physician. The total dose to the tumor bed or mastectomy scar cannot exceed 6600cGy.
Treatments will be given Monday through Friday.

After the completion of radiation therapy, patients will be seen on the following schedule:

A follow up examination will take place every 3-6 months for the first two years, then every
4-6 months for years for the next 3 years. After 5 years follow-up evaluations will occur
annually. A SPECT scan will be obtained at 6 months post therapy.

Patients must be 18 and older and must have histologically confirmed (by routine H&E
staining) invasive adenocarcinoma or Ductal Carcinoma In Situ of the left breast.

Patients must have also undergone a segmental mastectomy (SM) or Mastectomy.

Patients must not have received prior radiation therapy to the breast at any time for any
reason.

Patients must not be pregnant due to the potential for fetal harm as a result of this
treatment regimen.


Inclusion Criteria:



- Patient must be 18 and older

- Patients must have histologically confirmed (by routine H&E staining) invasive
adenocarcinoma or Ductal Carcinoma In Situ of the left breast.

- Patients must have undergone a segmental mastectomy (SM) or Mastectomy

- Patients must not have received prior radiation therapy to the breast at any time for
any reason.

- Any patient with active local-regional disease prior to registration is not eligible.

- Patients must not be pregnant due to the potential for fetal harm as a result of this
treatment regimen. Women of child-bearing age will be given a serum pregnancy test
prior to study entry to ensure they are not pregnant. Women of child-bearing
potential must use effective non-hormonal contraception while undergoing radiation
therapy.

- Patients must not have a serious medical or psychiatric illness which prevents
informed consent or compliance with treatment.

- All patients must be informed of the investigational nature of this study and give
written informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria:

- Patients requiring oxygen

- Sarcoma or Squamous Cell pathology

- Right-sided breast cancers

- Metastatic disease to the breast

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Test the efficacy of the ABC device in protecting the heart from radiation damage in patients with L breast cancer.

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Richard Zellars, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center- Dept. Radiation Oncology

Authority:

United States: Food and Drug Administration

Study ID:

J0609

NCT ID:

NCT00321048

Start Date:

June 2006

Completion Date:

October 2017

Related Keywords:

  • Breast Neoplasms
  • Carcinoma, Ductal
  • Adenocarcinoma
  • breast cancer
  • SPECT
  • ABC device
  • Invasive adenocarcinoma of the left breast
  • Ductal Carcinoma In Situ of the left breast
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Breast Neoplasms
  • Neoplasms
  • Carcinoma
  • Carcinoma, Ductal

Name

Location

The Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231