3-Dimensional Conformal Radiation Therapy or Internal Radiation Therapy After Breast-Conserving S… (NCT00802711) | Clinical Trial Compass
TerminatedNot Applicable
3-Dimensional Conformal Radiation Therapy or Internal Radiation Therapy After Breast-Conserving Surgery in Treating Women With Stage I or Stage II Breast Cancer
Stopped: Slow accrual
Ireland6 participantsStarted 2009-10
Plain-language summary
RATIONALE: Specialized radiation therapy, such as 3-dimensional conformal radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving these treatments after surgery may kill any tumor cells that remain after surgery. It is not yet known whether 3-dimensional conformal radiation therapy is more effective than internal radiation therapy when given after surgery in treating early-stage breast cancer.
PURPOSE: This randomized phase II trial is studying 3-dimensional conformal radiation therapy to see how well it works compared with internal radiation therapy when given after breast-conserving surgery in treating women with stage I or stage II breast cancer.
Who can participate
Age range
50 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:
* Pathologically proven invasive ductal carcinoma of the breast
* Stage I or II disease (pathological tumor size ≤ 3 cm, N0, M0 disease)
* No T2 (tumor size \> 3 cm) or T3 disease
* No lymph node (L0) or hemangiosis (V0) invasion
* Unilateral, unifocal, and unicentric tumor without associated suspicious diffuse microcalcification in the ipsilateral or contralateral breast
* No multifocal/multicentric disease
* Previously treated with breast-conserving surgery with adequate axillary node management
* Negative surgical resection margins for tumor (invasive tumor or ductal carcinoma in situ \[DCIS\]) on histology
* Clearly identified primary tumor excision cavity (clips recommended) with a target lumpectomy cavity/whole breast ratio quantifiable and ≤ 25% on the post-operative CT scan
* Patients with a lumpectomy cavity/whole breast ratio 25-30% are eligible but will undergo partial breast irradiation using multi-catheter interstitial brachytherapy during study
* Breast size amenable to partial breast irradiation (i.e., \> A-cup size)
* No other pathological invasive tumor or DCIS
* No associated extensive DCIS component (\< 25%)
* No associated Paget's disease of the nipple
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Menopausal status not specified
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No breast implants
* No collagen vascular disease
*…
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
Rate of successfully delivered accelerated partial breast irradiation