Single Pre-Operative Radiation Therapy (SPORT) for Low Risk Breast Cancer (SPORT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01717261|
Recruitment Status : Recruiting
First Posted : October 30, 2012
Last Update Posted : April 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Radiation: Single Pre-Operative Radiation Therapy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||May 2016|
|Estimated Study Completion Date :||May 2019|
|Experimental: Single Pre-Operative Radiation Therapy||
Radiation: Single Pre-Operative Radiation Therapy
Dose escalation: 3 patients will receive 15 Gy in a single fraction. The following 3 patients will receive 18 Gy. The final 4 patients will receive 20 Gy.
- Acute toxicity [ Time Frame: 6 months ]Assess acute toxicity and wound healing complications from the preoperative radiation treatment as per NCI CTCAE Common Toxicity Scale.
- Chronic toxicity [ Time Frame: 2 years ]Assess late-onset toxicity associated with a single fraction radiation treatement as per RTOG/EORTC Late Radiation Toxicity Scale
- Cosmetic outcome [ Time Frame: 5 years ]Cosmesis will be evaluated as per the EORTC Breast Cancer Cosmetic Rating scale.
- Ipsilateral breast cancer recurrence [ Time Frame: 5 years ]
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): NCT01717261
|Contact: Michael Yassa, MDemail@example.com|
|Montreal, Quebec, Canada, H1T 2M4|
|Contact: Linda Roy-Huneault 5142523425 firstname.lastname@example.org|
|Principal Investigator: Michael Yassa, MD|
|Study Chair:||Michael Yassa, MD||Maisonneuve-Rosemon Hospital|