Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00499057
Status:
UNKNOWN
Last Update Posted:
2014-12-23
First Post:
2007-07-09
Brief Title:
Partial Breast Irradiation With Interstitial High Dose Rate Brachytherapy
Sponsor:
University Of Perugia
Organization:
University Of Perugia
Study Overview
Official Title:
Interstitial High Dose-Rate Brachytherapy for Partial Breast Irradiation in Early Breast Cancer Results of Phase II Prospective Study
Status:
UNKNOWN
Status Verified Date:
2010-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Partial breast irradiation PBI is becoming more widespread in the treatment of early breast cancer in patients at low risk of relapse as pathological and clinical findings have demonstrated that most breast cancer recurrences after BCS occur close to the tumour bed In our phase II prospective study PBI is administered with high-dose-rate brachytherapy in patients with low-risk early-stage breast cancer Patients receive 4 Gy twice a day for 4 days total dose 32 Gy
Detailed Description:
Patients included in our phase II trial of PBI with interstitial HDR brachytherapy are at low-risk of relapse Implants are positioned during surgery or postoperatively within 12 weeks Treatment schedule is 4 Gy twice a day with a time relapse of at least 6 hours between each fraction for four days for a total dose 32 Gy Before post-operative implantation all patients undergo a breast computed tomography CT scan to visualize and expand the excision cavity and obtain the planning target volume PTV ie the lumpectomy cavity plus a margin of 1-2 cm around it Through virtual simulation with a 3D treatment planning system TPS we define the implant catheter position After implantation in all patients a breast CT scan checked implant geometry On CT images transferred to a TPS the surgical cavity is outlined and expanded the PTV defined and inactive and active source lengths measuredCT-based 3D software is used to identify and reconstruct the catheters outline and expand the surgical cavity and obtain the PTV Dwell positions are activated for each catheter and inactive and active lengths definedPrescribed dose was 85 of the basal dose Dwell weights are optimised in the basal points applying the volume and distance method and best values were chosen independently of strategy A dose-volume histogram that records the volume covered by 100 and 150 of the prescribed dose V100 and V150 was obtained for each patient DHI defined as V150 - V100 V100 7 is recognized as the most suitable quality index
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None