Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00337064
Status:
UNKNOWN
Last Update Posted:
2006-06-15
First Post:
2006-06-13
Brief Title:
Partial Breast Radiation to the Lumpectomy Cavity With IMRT in Elderly Women
Sponsor:
University of Vermont
Organization:
University of Vermont
Study Overview
Official Title:
Phase III Trial to Evaluate Partial Breast Radiation to the Region of the Lumpectomy Cavity Using Intensity Modulated Radiation in Elderly Women With Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2006-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The standard treatment for women with invasive breast cancer is local excision follow by whole breast radiation The local recurrence rates are low side effects are low and the cosmetic outcome is excellent The treatments however need to be given daily for 5 12 to 6 12 weeks making the treatment difficult particularly for the elderly and for women who need to travel long distances for the therapy The goal of this study is to determine the toxicity and efficacy of giving the radiation in a shorter time using higher daily doses of radiation
The risk of recurrence in the elderly population is lower and since majority of recurrences occur close to the area where the tumor previously was it is hypothesized that radiation to that area of the breast would be sufficient to obtain low risk of recurrence When a smaller volume of tissue is treated more radiation can be given daily and therefore the treatment can be shortened The risk of side effects increases as the dose per daily treatment increases Therefore the goal is to study the short term side effects long term side effects and cosmetic outcome of daily radiation using higher daily doses for shorter period of time We will also follow the recurrence rate Because less of the breast tissue will be treated there may be a small increased risk of recurrence Because the higher fraction size can result in more side effects we will be using intensity modulated radiation IMRT IMRT is the most advanced individually tailored radiation treatment technique that results in the least amount of side effects It allows tight monitoring of the dose in the untreated breast
Seventy five women diagnosed with stage I breast cancer will participate Participants must have a lumpectomy clear margins and no lymphovascular invasion to be eligible A treatment planning CT scan will be obtained If the lumpectomy cavity can be clearly delineated an IMRT plan will be generated with predefined strict dose requirement criteria The patients will be treated once daily 5 days a week for a total of 10 treatments instead of standard 28-33 The patients will be evaluated for toxicity weekly during the treatment and weekly for additional 4 weeks At each of these evaluations they will fill out a short 10 minute questionnaire detailing their side effects Follow-up will continue every 3 months for 3 years and every 6 months for 2 more years At each of these follow-ups a short questionnaire will be filled out by the patients detailing any toxicity as well as their perception of the cosmetic outcome A cosmesis questionnaire will be also be filled out by the evaluating physician before radiation at 6 12 18 and 24 months and yearly for 3 more years A total of 5 years of follow-up is planned Participants will also have the option of consenting to the photograph portion of the study Those who do will have photographs taken of their breasts excluding faces at the time they complete the cosmetic questionnaire to evaluate the cosmetic outcome
The risk of recurrence in the elderly population is lower and since majority of recurrences occur close to the area where the tumor previously was it is hypothesized that radiation to that area of the breast would be sufficient to obtain low risk of recurrence When a smaller volume of tissue is treated more radiation can be given daily and therefore the treatment can be shortened The risk of side effects increases as the dose per daily treatment increases Therefore the goal is to study the short term side effects long term side effects and cosmetic outcome of daily radiation using higher daily doses for shorter period of time We will also follow the recurrence rate Because less of the breast tissue will be treated there may be a small increased risk of recurrence Because the higher fraction size can result in more side effects we will be using intensity modulated radiation IMRT IMRT is the most advanced individually tailored radiation treatment technique that results in the least amount of side effects It allows tight monitoring of the dose in the untreated breast
Seventy five women diagnosed with stage I breast cancer will participate Participants must have a lumpectomy clear margins and no lymphovascular invasion to be eligible A treatment planning CT scan will be obtained If the lumpectomy cavity can be clearly delineated an IMRT plan will be generated with predefined strict dose requirement criteria The patients will be treated once daily 5 days a week for a total of 10 treatments instead of standard 28-33 The patients will be evaluated for toxicity weekly during the treatment and weekly for additional 4 weeks At each of these evaluations they will fill out a short 10 minute questionnaire detailing their side effects Follow-up will continue every 3 months for 3 years and every 6 months for 2 more years At each of these follow-ups a short questionnaire will be filled out by the patients detailing any toxicity as well as their perception of the cosmetic outcome A cosmesis questionnaire will be also be filled out by the evaluating physician before radiation at 6 12 18 and 24 months and yearly for 3 more years A total of 5 years of follow-up is planned Participants will also have the option of consenting to the photograph portion of the study Those who do will have photographs taken of their breasts excluding faces at the time they complete the cosmetic questionnaire to evaluate the cosmetic outcome
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None