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A Multi-Site, Prospective, Non-Randomized Study of the Contura™ Multi-Lumen Balloon (MLB) Catheter to Deliver Accelerated Partial Breast Irradiation: Analysis of Dosimetry, Local Tumor Control, Cosmetic Outcome, and Toxicity


Phase 4
50 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

A Multi-Site, Prospective, Non-Randomized Study of the Contura™ Multi-Lumen Balloon (MLB) Catheter to Deliver Accelerated Partial Breast Irradiation: Analysis of Dosimetry, Local Tumor Control, Cosmetic Outcome, and Toxicity


The Cancer Center of Irvine is one of the busiest centers in the United States for Contura
accelerated partial breast irradiation.


Inclusion Criteria:



- Able and willing to sign informed consent

- Age 50 or older at diagnosis

- Life expectancy greater than 10 years (excluding diagnosis of breast cancer)

- Surgical treatment of the breast must have been lumpectomy. The margins of the
resected specimen must be histologically free of tumor (negative surgical margins per
NSABP criteria)

- On histologic examination, the tumor must be DCIS and/or invasive breast carcinoma

- For patients with invasive breast cancer, an axillary staging procedure must be
performed [either sentinel node biopsy or axillary dissection (with a minimum of 6
axillary nodes removed), and the axillary node(s) must be pathologically negative]

- The T stage must be Tis, T1, or T2. If T2, the tumor must be less than or equal to
3.0 cm in maximum diameter

- Estrogen receptor positive tumor

Exclusion Criteria:

- Age < 50 at diagnosis (regardless of histology)

- Pregnant or breast-feeding

- Active collagen vascular disease

- Paget's disease of the breast

- Prior history of DCIS or invasive breast cancer

- Prior breast or thoracic radiation therapy for any condition

- Multicentric carcinoma (DCIS or invasive)

- Synchronous bilateral invasive or non-invasive breast cancer

- Surgical margins that cannot be microscopically assessed or that are positive

- Positive axillary node(s)

- T stage of T2 with the tumor > 3 cm in maximum diameter or a T stage of T3 or T4

- Estrogen receptor negative tumor

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum total skin dose is less than or equal to 125% of the prescribed radiation dose.

Outcome Time Frame:

19 months

Safety Issue:

Yes

Principal Investigator

Kenneth M Tokita, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Center of Irvine

Authority:

United States: Institutional Review Board

Study ID:

S07-002

NCT ID:

NCT00882596

Start Date:

May 2008

Completion Date:

December 2014

Related Keywords:

  • Breast Cancer
  • Contura
  • Cancer
  • Accelerated
  • Partial
  • Breast
  • Irradiation
  • Breast Neoplasms

Name

Location

Cancer Center of IrvineIrvine, California  92618