Partial Breast Irradiation Using Interstitial Permanent Palladium-103 Seed Implant (NCT02297672) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Partial Breast Irradiation Using Interstitial Permanent Palladium-103 Seed Implant
Canada75 participantsStarted 2015-02
Plain-language summary
Permanent Breast Seed Implant (PBSI) has been demonstrated to be a well accepted and well tolerated form of partial breast radiotherapy. This protocol aims to build on the initial experience and to further refine the technique and collect toxicity and cost data, especially in comparison to alternate forms of breast radiotherapy.
Who can participate
Age range55 Years – 80 Years
SexFEMALE
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Inclusion Criteria:
* Patient consent and signature of approved consent form.
* Age greater than 55 years and postmenopausal.
* Life expectancy of at least ten years
* Stage 0 or I breast cancer. Tumour size \< 2 cm.
* Invasive cancer must be pathologic grade 1 or 2
* Histology must be either Ductal Carcinoma In Situ or invasive ductal adenocarcinoma of the breast.
* Tumour removed by lumpectomy with clear margins (DCIS and invasive).
* Unifocal disease
* For invasive breast cancer, axillary staging by either sentinel node biopsy or axillary dissection (minimum of 6 axillary nodes). Not required for DCIS.
* Brachytherapy generally should be performed within 16 weeks of the last surgery (lumpectomy, re-excision of margins, or axillary staging procedure). If \> 16 weeks, will be assessed on case-by-case basis, based on seroma visibility and the presence of surgical clips in the tumour bed.
* Tumour must be Estrogen Receptor positive.
* The lumpectomy cavity (seroma) must be clearly delineated by ultrasound and CT and should be \< 3 cm diameter (equivalent sphere) resulting in a maximum of 125 cc planning target volume (PTV).
* Breast seed implant must be considered technically deliverable by interstitial brachytherapy by the attending radiation oncologist and must be a minimum 2-plane implant.
* If prior non-breast malignancies, must have been disease-free for 5 or more years. Time limit waived for carcinoma in-situ of the cervix or colon, melanoma i…