Trial record 3 of 153 for:
St. Joseph Hospital AND Orange AND CA | Open Studies
Single Fraction Intraoperative Radiotherapy
This study is currently recruiting participants.
Verified September 2012 by St. Joseph Hospital of Orange
Sponsor:
St. Joseph Hospital of Orange
Information provided by (Responsible Party):
St. Joseph Hospital of Orange
ClinicalTrials.gov Identifier:
NCT01688388
First received: September 12, 2012
Last updated: September 20, 2012
Last verified: September 2012
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Purpose
This clinical trial is being conducted to find out the effects (good and bad) of giving the full radiation treatment for breast cancer as a single dose of radiation during surgery for breast cancer. This single fraction intraoperative radiotherapy with electrons will study the toxicity, local control and cosmetic outcome.
| Condition | Intervention | Phase |
|---|---|---|
|
Invasive Ductal and Invasive Lobular Breast Carcinoma Stage 0 Breast Carcinoma Stage I Breast Carcinoma Stage II Breast Carcinoma |
Procedure: Intraoperative Radiotherapy |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Single Fraction Intraoperative Radiotherapy With Electrons: An Option in Breast-Conserving Operable Breast Cancer Stages 0, I and II - Prospective, Single-arm Trial |
Resource links provided by NLM:
Further study details as provided by St. Joseph Hospital of Orange:
Primary Outcome Measures:
- Toxicity Assessment [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Assessment of acute toxicity of breast irradiation according to CTC-toxicity Scoring - system:
- End of initial surgical phase: Week 1, 4
- First Follow-up investigation: Month 2 Assessment of late toxicity according to NSABP scoring-systems at 6, 12, 24, 36, 48, and 60 months
Secondary Outcome Measures:
- Cosmetic Evaluation [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Assessment of cosmetic outcome according to 5-point scoring system
- Week 1, 2; Month 2, 6, 12, 24, 36, 48, 60
- At yearly follow-up (photodocumentation in standardized positions) for 5 years
- Recurrence Assessment [ Time Frame: 5 years ] [ Designated as safety issue: No ]Recurrence is assessed at month 6, 12, 24, 36, 48, 60
| Estimated Enrollment: | 200 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | February 2022 |
| Estimated Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: IORT Arm
Intraoperative radiotherapy (IORT) is delivered after completion of the lumpectomy and sentinel node procedure.
|
Procedure: Intraoperative Radiotherapy
Intraoperative radiotherapy (IORT) is delivered after completion of the lumpectomy and sentinel node procedure. IORT is performed on mobile or fixed linacs with variable electron energies in the range of 6-12 MeV prescribed to a dose of 21 Gy, with the prescription dose covering at least 90% of the Planning Target Volume (PTV). PTV is defined as a 3D volume of 1-2 cm beyond the former macroscopic tumor edge (excluding skin, limit to anterior rib surface: 5 Gy). The choice of electron energy as well as the cone applicator size has to account for minimum PTV requirements. Tissue depth measurement will be documented by intraoperative sonography.
Other Name: IORT
|
Detailed Description:
For patients with certain types of breast cancer, one standard treatment is breast conserving surgery or lumpectomy (surgery to remove abnormal tissue or cancer from the breast and a small amount of normal tissue around it) followed by breast radiation. The radiation treatment in this situation usually lasts 3 to 5 1/2 weeks followed by 5-8 daily localized irradiation (or boost) treatments at the site where the lump was removed. During this study, the single dose of electron irradiation given at the surgical site during the operation will replace the radiation given after surgery.
Eligibility| Ages Eligible for Study: | 41 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histological proven invasive breast carcinoma ductal, lobular and/or Ductal Carcinoma in situ
- Age > 40 years
- Karnofsky performance status > 70%
- Tumor. Single discrete tumor or focal microcalcifications that can be imaged on a specimen radiograph or multifocal disease within the same quadrant with a maximum dimension of equal to or less than 2.5 cm
- Nodal Status: preoperatively N0
- Clear surgical margins: R0
- All grades G1 - G3
- Any hormonal receptor and HER-2 status
- Informed consent
Exclusion Criteria:
- Gender: male
- Tumor size: more than 2.5 cm
- Nodal status greater than or equal to N1 pathologically
- Multicentricity
- Previous radiotherapy to the involved breast
- Karnofsky Index < 70%
- Mixed connective tissue diseases e.g. rheumatoid poly arthritis, thromboangitis obliterans, systemic lupus
- Distant metastases
- Pregnancy in woman of child bearing age
- Unable to provide written consent
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01688388
Contacts
| Contact: Heather Weiss, BS | 714-734-6220 ext 40838 | Heather.Weiss@stjoe.org |
| Contact: Carmen Moronez |
Locations
| United States, California | |
| St. Joseph Hospital of Orange | Recruiting |
| Orange, California, United States, 92868 | |
| Contact: Heather Weiss, BS 714-734-6220 ext 40838 Heather.Weiss@stjoe.org | |
| Contact: Carmen Moronez | |
| Principal Investigator: Afshin Forouzannia, M.D. | |
Sponsors and Collaborators
St. Joseph Hospital of Orange
Investigators
| Study Chair: | Lawrence Wagman, M.D. | St. Joseph Hospital of Orange |
More Information
No publications provided
| Responsible Party: | St. Joseph Hospital of Orange |
| ClinicalTrials.gov Identifier: | NCT01688388 History of Changes |
| Other Study ID Numbers: | 12-001 Single Fraction IORT |
| Study First Received: | September 12, 2012 |
| Last Updated: | September 20, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by St. Joseph Hospital of Orange:
|
Breast Cancer Carcinoma Radiotherapy Intraoperative Radiotherapy IORT |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Ductal, Lobular, and Medullary |
Carcinoma Carcinoma in Situ Carcinoma, Lobular Breast Diseases Skin Diseases Adenocarcinoma |
ClinicalTrials.gov processed this record on May 22, 2013