Multi-catheter High Dose Rate (HDR) Breast Brachytherapy

NCT00214149 | Terminated Phase 2 Results DMC

• 2 other identifiers: RO041022004-0268
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

Brief Summary

Breast conservation therapy (BCT) is now widely accepted as a treatment option for most women with Stage I and II invasive breast cancer and most patients with ductal carcinoma in situ (DCIS). Despite superior cosmetic outcome, BCT is more complex and requires a protracted treatment regimen comprised of 6 weeks of daily external beam radiation therapy to the whole breast. The purpose of this study is to determine if an acceptable outcome can be achieved with radiation delivered only to the region of the tumor bed. If this is true, partial breast irradiation may lend itself to much shorter treatment times (one week) and the toxicities to adjacent normal structures (heart, lung, chest wall) will be greatly reduced.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• To Determine if Brachytherapy Will Produce Non-inferior Local Regional Control at 5 Years Post Treatment When Compared to Historical Results of Conventional XRT

  5 years

Secondary Outcomes (1)

• To Determine if Brachytherapy Will Produce Non-inferior Toxicity to XRT at 3 Years

  3 years

Study Arms (1)

1

EXPERIMENTAL

breast brachytherapy to a dose of 34 Gy

Radiation: brachytherapy

Interventions

brachytherapy RADIATION

breast brachytherapy to 34 Gy

1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Invasive breast cancer or DCIS, tumor stage of Tis, T1, T2 if lesion is \< 3 cm, N0 or N1 if 1-3 + nodes with no extracapsular extension

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

• McHaffie DR, Patel RR, Adkison JB, Das RK, Geye HM, Cannon GM. Outcomes after accelerated partial breast irradiation in patients with ASTRO consensus statement cautionary features. Int J Radiat Oncol Biol Phys. 2011 Sep 1;81(1):46-51. doi: 10.1016/j.ijrobp.2010.05.011. Epub 2010 Aug 21.

  PMID: 20732760 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Brachytherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Limitations and Caveats

We were able to find a published paper that may represent some of the results of this study (linked in the references section of the protocol). The number of participants does not match our records as our records for this study are incomplete.

Results Point of Contact

• Title: Diana Trask, research coordinator for study
• Organization: UW Hospital and Clinics

trask@humonc.wisc.edu

608-263-9528

Study Officials

• Rakesh Patel, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: October 1, 2004
• Primary Completion: April 1, 2008
• Study Completion: October 1, 2010
• Last Updated: November 5, 2018
• Results First Posted: November 5, 2018

Record last verified: 2018-10

Locations

US (1)