A Registry Study of Permanent Breast Seed Implant
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|ClinicalTrials.gov Identifier: NCT01106521|
Recruitment Status : Recruiting
First Posted : April 20, 2010
Last Update Posted : March 1, 2013
Women found to have early stage breast cancer will have their cancer surgically removed followed by radiation treatment to the entire breast, five times per week for several weeks. The radiation treatment prevents the cancer from growing back but creates skin burns. Several studies have showed that it is nor necessary treating the whole breast.
The investigators team has pioneered a new therapy realizing the permanent implantation of tiny radioactive seeds into the surgical cavity in a single one hour procedure under light anesthesia. Patients live a normal life while receiving the radiation treatment. The results of a first clinical trial on 67 patients shows that the treatment is well tolerate and efficient. The purpose of the study is to offer the treatment in several places and to increase the cohort of patient to 420 to capture rare complications if any.
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms||Radiation: Permanent breast seeds implant||Not Applicable|
For early stage breast cancer, accelerated partial breast irradiation is an alternative treatment option to whole breast irradiation after breast conserving surgery. Our group has previously reported results of a Phase I/II study of permanent breast seed implant (PBSI) using palladium-103 seeds as an alternative to whole breast radiotherapy for well selected breast cancer patients. The procedure is realised in a single session under light sedation and local freezing. After a median FU of 54 months no patients has recurred on a cohort of 67 patients, and acute of delayed side effect compared favourably to external beam radiotherapy.
Yet this study was a single centre study and the sample size did not allow evaluating appropriately the risk of serious adverse events (SAE). The current study propose evaluating SAE on a multicentre and larger cohort of 420 patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||420 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicentre Registry Study of Permanent Breast Seed Implant (PBSI) for Early Stage Breast Cancers.|
|Study Start Date :||March 2009|
|Estimated Primary Completion Date :||March 2014|
|Estimated Study Completion Date :||March 2024|
PBSI is a form of accelerated partial breast irradiation involving the insertion of 103-palladium stranded seeds under ultra-sound guidance and light sedation after CT planning in lieu of whole breast adjuvant radiotherapy.
Radiation: Permanent breast seeds implant
Patients are pre-planned using CT simulation. Implant is realised under light sedation and local freezing. Stranded seeds are inserted using a brachytherapy template that is immobilised to the planned target volume using a 'localization' needle. Patients is released the same day and Quality Assurance involves a 2 months post-implant CT
Other Name: Artemend
- Serious Adverse Events [ Time Frame: Initial and then yearly up to 5 years ]Serious Adverse Events (SAE) is an unintended sign, symptom, or syndrome illness that occurs during the period of observation in the clinical study and that is life threatening or result in death. SAE will be coded using the NCI CTC V3.0 scale and corresponds to grade 4 or 5 signs or symptoms.
- Breast cancer local recurrence [ Time Frame: Yearly up to 10 years ]Ipsilateral in-breast or chest wall recurrence is defined as evidence of invasive or in situ breast cancer (except LCIS) in the ipsilateral breast. Patients will have a biopsy of the suspicious lesion to confirm the diagnosis with documentation of the location.
- Regional recurrence [ Time Frame: Yearly up to 10 years ]Regional recurrence is defined as the development of tumor in regional nodes as well as the soft tissue of the ipsilateral axilla after axillary dissection. The regional recurrence is suspected on imaging and/or clinical symptoms and must be documented with fine needle aspiration. Also the localisation of the nodal recurrence must be reported (internal mammary chain, supra-clavicular area or axilla).
- Metastases [ Time Frame: Yearly up to 10 years ]Distant recurrence is defined as evidence of tumor in any area of the body. The metastasis recurrence should be proved by appropriate imaging, biopsy or fine needle aspiration
- PBSI side effects [ Time Frame: After procedure ]Any toxicity related to the radiation treatment, including skin and subcutaneous, or any other organ in case of seed migration will be coded using the NCI common toxicity criteria version 3.0 scale.
- PBSI side effects [ Time Frame: At 2 months ]Any toxicity related to the radiation treatment, including skin and subcutaneous, or any other organ in case of seed migration will be coded using the NCI common toxicity criteria version 3.0 scale.
- PBSI side effect [ Time Frame: At 6 months ]Any toxicity related to the radiation treatment, including skin and subcutaneous, or any other organ in case of seed migration will be coded using the NCI common toxicity criteria version 3.0 scale.
- PBSI side effect [ Time Frame: Yearly up to 10 years ]Any toxicity related to the radiation treatment, including skin and subcutaneous, or any other organ in case of seed migration will be coded using the NCI common toxicity criteria version 3.0 scale. Fat necrosis will be diagnosed either by mammography or clinically (prolonged indurations and pain in the area of seeds implantation without evidence of infection).
- Cosmetic outcome [ Time Frame: Yearly up to 10 years ]Cosmetic results will be evaluated at each follow-up visit by the treating radiation oncologist. An excellent cosmetic result score is assigned when the treated breast looked essentially the same as the contralateral breast (as it relates to radiation effects). A good cosmetic score is assigned for minimal but identifiable radiation effects of the treated breast. A fair score means significant radiation effects were readily observable. A poor score is used for severe sequelae of breast tissue secondary to radiation effects.
- Survival [ Time Frame: Yearly up to 10 years ]Patient survival, either free of cancer or with disease present will be recorded at follow-up appointments.
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): NCT01106521
|Contact: Jean-Philippe Pignol, MD, PhD||416 480 6100 ext email@example.com|
|Contact: Eileen Rakovitch, MSc||416 480 6100 ext firstname.lastname@example.org|
|Sunnybrook Odette Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M4N3M5|
|Contact: Jean-Philippe Pignol, MD, PhD 416 480 6100 ext 5329 email@example.com|
|Contact: Eileen Rakovitch, MSc 416 480 6100 ext 4806 firstname.lastname@example.org|
|Principal Investigator: Jean-Philippe Pignol, MD, PhD|
|Sub-Investigator: Eileen Rakovitch, MSc|
|Study Chair:||Jean-Philippe Pignol, MD, PhD||Sunnybrook Health Sciences Centre|