Radiation Therapy During Surgery in Treating Older Women With Invasive Breast Cancer (NCT00182728) | Clinical Trial Compass
CompletedNot Applicable
Radiation Therapy During Surgery in Treating Older Women With Invasive Breast Cancer
United States89 participantsStarted 2003-03-18
Plain-language summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation during surgery may be an effective treatment for breast cancer.
PURPOSE: This phase II trial is studying how well radiation therapy works in treating older women who are undergoing surgery for invasive breast cancer.
Who can participate
Age range
48 Years – 120 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically confirmed primary invasive ductal carcinoma of the breast
* Tumor size ≤ 3 cm
* No extensive intraductal component
* Tumor must not be attached to the skin, underlying muscle, or chest wall
* Candidate for breast-conserving therapy, as determined by the surgical and radiation oncologist
* Tumor amenable to segmental mastectomy (i.e., lumpectomy)
* No bilateral breast cancer
* No clinical or radiographic multifocal disease not amenable to single segmental mastectomy
* Patients with \> 1 tumor mass in the same breast must have only 1 mass that is histologically malignant AND all other masses must be proven histologically benign
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* 48 and over
Sex
* Female
Menopausal status
* Not specified
Performance status
* 0-2
Life expectancy
* At least 5 years
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Other
* Not pregnant
* Fertile patients must use effective contraception
* No collagen vascular disease
* No medical condition that would preclude surgery
* Other prior malignancy allowed provided the following criteria are met:
* Patient has undergone potential curative therapy for all prior malignancies
* There is no evidence of any prior malignancy within the past 5 years
* Patient is deemed to be at low risk for recurrence of prior malignancy, as determined by the treating physician
PRIOR CONCURRENT TH…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rates of Good/Excellent Cosmesis as Measured by the Radiation Therapy Oncology Group (RTOG) Cosmetic Rating Scale - Rated by Physician
Timeframe: 1 year follow up visit
2
Rates of Good/Excellent Cosmesis as Measured by the Radiation Therapy Oncology Group (RTOG) Cosmetic Rating Scale - Rated by Patients