Pilot Study of Partial Breast Irradiation Utilizing Permanent Breast Seed Implant to Treat Breast Cancer
|ClinicalTrials.gov Identifier: NCT01191164|
Recruitment Status : Unknown
Verified August 2011 by British Columbia Cancer Agency.
Recruitment status was: Not yet recruiting
First Posted : August 30, 2010
Last Update Posted : August 25, 2011
Background: Recent single arm studies have suggested that partial breast irradiation (PBI), delivered in a relatively short overall treatment time of a few days, may be an effective alternative to adjuvant whole breast irradiation (WBI) delivered over a number of weeks. Several PBI modalities and techniques have been investigated, including interstitial brachytherapy and external beam radiation therapy, most often given over the course of one week of twice daily outpatient treatments. One randomized study has shown equivalency between WBI and PBI using brachytherapy. There are currently three large phase-III randomized studies comparing PBI to WBI.
Permanent Breast Seed Implant (PBSI) is the newest PBI technique which has been piloted at the Odette Cancer Centre (OCC) in Toronto. The main advantage of this technique is that it requires only one out-patient procedure. The treatment is administered by implanting radioactive Palladium (103Pd) seeds into the tumor bed region in a 1 to ½ hour outpatient procedure, after which the patient is discharged home to resume her normal living activities. This PBI procedure was shown to be well tolerated with minimal acute toxicity. Estimated partner radiation exposure was well within internationally acceptable levels. Subjects with a seroma >2cm were, however, excluded.
Hypothesis: PBSI is a feasible, safe, and acceptable treatment option for the subject and her partner in the context of medical practice and resources in BC.
Objectives: In subjects who have undergone breast conserving surgery for early breast cancer:
- To determine the technical feasibility of PBSI in BC
- To measure the subject's partner in terms of radiation protection
- To evaluate acceptability of PBSI by the subject
- To assess resource requirements for PBSI
Method: This is a single arm feasibility study. Five women who had undergone breast conserving surgery for breast cancer with low risk of local recurrence will be accrued. This study will adhere to a detailed written protocol for radiation measurements and protection.
Subjects will undergo PBSI within 4-14 weeks from last breast surgery. The procedure will be performed in an outpatient setting, under conscious sedation and local anesthesia, by a team with a wide brachytherapy experience. The technique used in this feasibility study will be based on the OCC technique. It is intended that two oncologists and one physicist will spend 2-3 days at the OCC to acquire detailed and firsthand knowledge of the technique as implemented at that centre.
The OCC technique is US-based; in this study, however, an additional CT-assisted planning component will be investigated building on the experience of the VIC team which conducted the BC Cancer Agency Vancouver Island Centre's pilot study of CT-based multi-catheter brachytherapy PBI.
Systemic therapy will be according to BCCA guidelines; however, subjects requiring adjuvant chemotherapy will be excluded from this study. Subjects will be followed prospectively for 5 years for evaluation of toxicity, QOL and cosmesis. Disease status will be recorded.
Relevance: Completing adjuvant breast irradiation with a single out-patient treatment could significantly improve QOL and convenience for patients choosing breast conserving therapy. Confirming the technical feasibility and safety of PBSI is needed before progressing to larger prospective evaluation of this novel adjuvant radiation therapy technique as a viable treatment option for women in British Columbia.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: Partial Breast Irradiation Utilizing Permanent Breast Seed Implant||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Study to Evaluate the Feasibility of Partial Breast Irradiation Utilizing Permanent Breast Seed Implant in British Columbia|
|Study Start Date :||September 2011|
|Estimated Primary Completion Date :||September 2016|
|Estimated Study Completion Date :||September 2016|
|Experimental: Study Arm||
Procedure: Partial Breast Irradiation Utilizing Permanent Breast Seed Implant
Target Volumes: The surgical cavity will be assessed with US & CT scans. The Clinical Target Volume (CTV) will encompass the surgical cavity plus 1 cm uniform expansion. The Planning Target Volume (PTV) will be the CTV plus 0.5 cm.
Dose Selection/Prescription: A minimal peripheral dose of 90 Gy (same as in the OCC study) will be prescribed to the PTV. This dose is chosen as biologically equivalent, over a 2 month period, to 50Gy in 25 fractions, for α/β of 2Gy54.
Implant Procedure and QA: This will be performed as an outpatient procedure under conscious sedation and local anesthesia, by a team with several years experience in brachytherapy and conscious sedation administration. The technique used in this pilot study will be based on the OCC technique. It is intended that two oncologists and one physicist will spend 2-3 days at the OCC to acquire detailed and firsthand knowledge of the technique and its implementation at that centre.
Other Name: Brachytherapy
- Technical parameters of the implant [ Time Frame: Measured once for each subject at a post-implant CT on the same day as the implant procedure. Will be assessed collectively once treatment is completed for all 5 subjects. ]
Implant technical parameters will include:
- SC (Surgical Cavity/Seroma) volume (average & range)
- PTV (average & range)
- Number of seeds per implant (average & range)
- Average total seed activity per implant
From DVH, average and range of:
- Number of seeds at a distance 5 mm or less from the skin surface
- Absolute (cc) and proportional (%) volume of ipsilateral breast receiving 90%, 50% and 10 % of the prescribed dose
- Seed motion at 1 month [ Time Frame: Measured once for each subject at CT performed 1 month after implant procedure. Will be assessed collectively once treatment is completed for all 5 subjects. ]Seed motion at 1 month will be determined from CT performed one month after PBSI
- Exposure Dose (ED) average and range for close partners [ Time Frame: Once per week for 4 weeks following implant ]For the purpose of this study, the subject and her partner, if any, will be asked to wear a small, unobtrusive, radiation measuring device around one arm for a period of 4 weeks. The amount of radiation from the breast implant to the subject and partner (if any) will be measured once per week for 4 weeks, during which time the level of radiation from the breast will become so low that subject will no longer need to wear the patch.
- Acute radiation toxicity [ Time Frame: Prior to implant, and at 1, 4 & 12 weeks after implant. ]Acute Toxicity Assessment: Acute toxicity will be assessed by a clinical trial nurse or clinical research associate (CRA) using the NCI Common Toxicity Criteria for Adverse Events (NCI CTCAE), Version 3.0 (see Appendix V). Acute toxicity will be assessed prior to PBSI and 1, 4 & 12 weeks post-PBSI.
- Adverse cosmetic outcome as a measure of late radiation morbidity [ Time Frame: Before implant, at 1, 3 and 5 years post-implant. ]Late Radiation Toxicity Assessment: Late RT toxicity will be assessed by a clinical trial nurse or CRA using the relevant items from the RTOG/EORTC late RT toxicity scale58, subject-administered OCOG Cosmetic Module, EORTC Cosmetic Rating System, and Digital Photographs for Cosmetic Assessment.
- Subject's Quality of Life [ Time Frame: 2 weeks prior to the procedure and at 1, 4 & 12 weeks and 1, 3 & 5 years follow-up visits. ]Quality of Life Assessment: Quality of life will be assessed using the self administered EORTC Quality of Life QLQ C-30 Questionnaire within the 2 weeks prior to the procedure and at 1, 4 & 12 weeks and 1, 3 & 5 years follow-up visits.
- Subject satisfaction [ Time Frame: 1 and 12 weeks after implant ]Subject Satisfaction with the PBSI procedure: Subject satisfaction with the procedure will be assessed using a specifically designed questionnaire, administered at 1 and 12 weeks follow-up visits.
- Average human resource cost per a PBSI, including oncologists, physicists, therapists, and nursing time (time spent by different personnel on various treatment components). [ Time Frame: After completion of implant procedure and 5 years of follow up. ]
- Cost of seeds and consumables for each implant (and relationship to PTV). [ Time Frame: After completion of implant procedure. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01191164
|Contact: Hosam A Kader, MD||250-519-5576||HKader@bccancer.bc.ca|
|Canada, British Columbia|
|British Columbia Cancer Agency||Not yet recruiting|
|Victoria, British Columbia, Canada, V8R 6V5|
|Principal Investigator: Hosam A Kader, MD|
|Sub-Investigator: Abraham Alexander, MD|
|Sub-Investigator: Tanya Berrang, MD|
|Principal Investigator:||Hosam A Kader, MD||BCCA, Department of Radiation Oncology|