Breast CancerNCT01191164
Pilot Study of Partial Breast Irradiation Utilizing Permanent Breast Seed Implant to Treat Breast Cancer
A study testing Partial Breast Irradiation Utilizing Permanent Breast Seed Implant in people with Breast Cancer, run by British Columbia Cancer Agency at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 60 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Partial Breast Irradiation Utilizing Permanent Breast Seed Implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2011to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Female subject with a pathologically-confirmed diagnosis of invasive ductal carcinoma.
- Tumor size < 2cm.
- Negative axillary node involvement, determined by either
- Sentinel node biopsy,
- Axillary node dissection removing > 6 nodes
- No evidence of metastatic disease.
- Treated by BCS with microscopically clear resection margins (> 2mm to ink) for invasive and non-invasive disease or no residual disease on re-excision.
Who cannot join
- Age < 60 years.
- Subjects who will receive adjuvant chemotherapy.
- A known deleterious mutation in BRCA-1 and/or BRCA-2.
- Extensive DCIS, mammographically or pathologically.
- Tumor histology of pure lobular carcinoma (invasive or in-situ).
- Adenoid cystic and non-epithelial malignancies (e.g. sarcoma or lymphoma).
Show all 24Show fewer
- Lymphovascular invasion (LVI) present.
- Bilateral invasive malignancy of the breast (synchronous or metachronous).
- More than one ipsilateral breast primary tumor.
- Previous irradiation to the ipsilateral breast.
- Presence of an ipsilateral breast implant.
- Serious non-malignant disease that precludes radiation treatment or conscious sedation.
- Unable for any reason to undergo PBSI within 14 weeks of the last breast surgery.
- Concomitant malignancies, except non-melanoma skin cancer and carcinoma in situ of any site.
- Significant persistent post-surgical complications.
- Currently pregnant or lactating.
- Psychiatric or addictive disorders which would preclude obtaining informed consent.
- Subject not committed to at least 3 years of follow-up.
- Low CBC levels: HB < 100 - Platelets < 100 - Neutrophil count < 1
- Close partner not consenting
- Inability to confidently localize/delineate the surgical cavity on CT and/or US.
- Subject not suitable for a minimum 2-plane implant based on tumor location/breast size.
- Seroma exceeding 3cm
- Seroma within the inner quadrants
Trial locations and contacts
1 site in 1 country.
Canada1 site
British Columbia Cancer Agency
Victoria, British Columbia, V8R 6V5
Hosam A Kader, MD
Abraham Alexander, MD
About this study
Official title: A Prospective Study to Evaluate the Feasibility of Partial Breast Irradiation Utilizing Permanent Breast Seed Implant in British Columbia
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.
Read more
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.
- Conditions
- Breast Cancer
- Being tested
- Partial Breast Irradiation Utilizing Permanent Breast Seed Implant
- Keywords
- Brachytherapy, Partial Breast Irradiation, Breast Seed Implant, Palladium Seeds
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial Breast Irradiation Utilizing Permanent Breast Seed ImplantProcedure or surgery
Also called Brachytherapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Experimental | Not described Receives: Procedure: Partial Breast Irradiation Utilizing Permanent Breast Seed Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical parameters of the implant
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:
- V90
- V100
- V150
- V200
- DHI
- 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
Measured: 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.
Seed motion at 1 month
Seed motion at 1 month will be determined from CT performed one month after PBSI
Measured: 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.
Exposure Dose (ED) average and range for close partners
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.
Measured: Once per week for 4 weeks following implant
Acute radiation toxicity
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.
Measured: Prior to implant, and at 1, 4 & 12 weeks after implant.
Adverse cosmetic outcome as a measure of late radiation morbidity
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.
Measured: Before implant, at 1, 3 and 5 years post-implant.
Subject's Quality of Life
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.
Measured: 2 weeks prior to the procedure and at 1, 4 & 12 weeks and 1, 3 & 5 years follow-up visits.
Subject satisfaction
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.
Measured: 1 and 12 weeks after implant
Secondary outcomes (2)
Average human resource cost per a PBSI, including oncologists, physicists, therapists, and nursing time (time spent by different personnel on various treatment components).
Measured: After completion of implant procedure and 5 years of follow up.
Cost of seeds and consumables for each implant (and relationship to PTV).
Measured: After completion of implant procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2010 (estimated)
- Study startSep 2011
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Collaborators
- BC Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Hosam A Kader, MD, Principal investigator, BCCA, Department of Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01191164
- Sponsor's protocol ID
- BCCA-H09-01053
- Status last verified
- Aug 2011
- First submitted
- 25 Aug 2010
- Last updated
- 25 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate the Feasibility of Partial Breast Irradiation Utilizing Permanent Breast Seed Implant in British Columbia
- ClinicalTrials.gov ID
- NCT01191164
- Acronym / sponsor ID
- BCCA-H09-01053
- Conditions
- Breast Cancer
- Keywords
- Brachytherapy, Partial Breast Irradiation, Breast Seed Implant, Palladium Seeds
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Collaborators
- BC Cancer Foundation
- Study start
- Sep 2011
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 30 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Experimental | Procedure: Partial Breast Irradiation Utilizing Permanent Breast Seed Implant |
Who may qualify
- Ages
- Up to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Female subject with a pathologically-confirmed diagnosis of invasive ductal carcinoma.
- Tumor size < 2cm.
- Negative axillary node involvement, determined by either
- No evidence of metastatic disease.
- Treated by BCS with microscopically clear resection margins (> 2mm to ink) for invasive and non-invasive disease or no residual disease on re-excision.
Key exclusion criteria (24 listed)
- Age < 60 years.
- Subjects who will receive adjuvant chemotherapy.
- A known deleterious mutation in BRCA-1 and/or BRCA-2.
- Extensive DCIS, mammographically or pathologically.
- Tumor histology of pure lobular carcinoma (invasive or in-situ).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partial Breast Irradiation Utilizing Permanent Breast Seed ImplantAlso: BrachytherapyTarget 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. | Procedure or surgery | Study Arm |
Primary outcome
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: * V90 * V100 * V150 * V200 * DHI * 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.
2 secondary outcomes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hosam A Kader, MD principal investigator
BCCA, Department of Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partial Breast Irradiation Utilizing Permanent Breast Seed Implant in people with Breast Cancer, run by British Columbia Cancer Agency at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hosam A Kader, MD (250-519-5576, HKader@bccancer.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2011.