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 range50 Years – 120 Years

SexFEMALE

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 *…

What they're measuring

Rate of successfully delivered accelerated partial breast irradiation

Timeframe: Never established as trial terminated

Trial details

NCT IDNCT00802711

SponsorCancer Trials Ireland

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2011-08