Feasibility Study of Stereotactic Body Radiotherapy for Early Breast Cancer (ARTEMIS)
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|ClinicalTrials.gov Identifier: NCT02065960|
Recruitment Status : Recruiting
First Posted : February 19, 2014
Last Update Posted : March 31, 2015
Most women with early breast cancer are treated with breast conserving therapy (BCT), consisting of breast conserving surgery (surgery to remove the cancer itself) followed by radiation to the breast. This treatment can take time and is associated with its own side effect profile. An innovative radiation technique called stereotactic body radiotherapy (SBRT) can deliver large doses of radiation precisely to the tumour while avoiding critical organs, therefore destroying the cancer and avoiding surgery altogether. SBRT has been successfully used for a number of cancers and it is proposed that it could be used to eradicate breast cancer. This feasibility study will investigate the feasibility and safety of treatment using SBRT in women with early stage breast cancer.
Thirty-two women age 70 years or older with early breast cancer will be treated with SBRT (5 treatments) followed by breast conserving surgery and hormonal therapy. An MRI and breast conserving surgery will be performed at 8-12 weeks after radiation to assess response to treatment. The primary outcome of the study will be feasibility, meaning the ability to deliver radiation treatment as planned. Secondary outcomes will include treatment related toxicity and pathological response.
If this study shows that SBRT can be used to treat patients primarily, it will lead to further evaluation of SBRT for early breast cancer.
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasm||Radiation: Stereotactic body radiotherapy (SBRT)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility Study of the Role of Stereotactic Body Radiotherapy for the Treatment of Early Stage Breast Cancer|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||June 2020|
Experimental: Stereotactic body radiotherapy (SBRT)
Radiotherapy with SBRT to a dose of 40 Gy in 5 fractions delivered every other day over a period of 10-12 days, followed by breast conserving surgery.
Radiation: Stereotactic body radiotherapy (SBRT)
Other Name: Cyberknife
- Feasibility [ Time Frame: At time of radiation treatment delivery ]The primary outcome for this study will be successful delivery of SBRT as per protocol without a major deviation.
- Acute Radiation Toxicity [ Time Frame: Within 3 months from radiation ]
- Late Radiation Toxicity [ Time Frame: 3 months or more after radiation ]
- Pathological Response [ Time Frame: At time of surgery (10-12 weeks post-radiation) ]
- Ipsilateral Breast Tumour Recurrence [ Time Frame: At 5 years post-registration ]
- Disease Free Survival [ Time Frame: At 5 years post-registration ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02065960
|Contact: Shelley Chambers, MA||905-387-9711 ext firstname.lastname@example.org|
|Contact: Julie Arsenault, MD, FRCPCemail@example.com|
|Juravinski Cancer Centre||Recruiting|
|Hamilton, Ontario, Canada, L8V 5C2|
|Principal Investigator:||Julie Arsenault, MD, FRCPC||Juravinski Cancer Centre|
|Principal Investigator:||Do-Hoon Kim, BASc, MD, MSc, FRCPC||Juravinski Cancer Centre|
|Principal Investigator:||Timothy Whelan, BSc, BM,BCh, MSc, FRCPC||Juravinski Cancer Centre|