Table 4 Summary of the clinical trials regarding pre-operative breast cancer radiotherapy in single fraction
Trial ID | Status | Title | Treatment | Description/endpoint | Primary outcome measure | Estimated/ actual primary completion date |
|---|---|---|---|---|---|---|
NCT03863301 | Recruiting | MRI-guided single dose preoperative RT in low-risk BC | MR-guided single dose preoperative PBI Dose: a single dose of 20 Gy to GTV and 15 Gy to CTV (GTV + 20 mm margin). Breast conserving surgery will be performed 12 months following PBI. | Evaluate efficacy of the treatment 12 months after RT, and to collect data on response monitoring (MRI, liquid biopsies and biopsy of the irradiated tumor). Patient-reported outcome measures will be evaluated. | pCR | November 2022 |
NCT02482376 | Recruiting | Preoperative single-fraction RT in early-stage BC | Stereotactic body RT Dose: a single fraction of 21Gy. Then standard of care surgery. | Assess toxicity, efficacy and to provide an avenue for understanding breast cancer radiation response through pre- and post-radiation breast tumor samples | Physician reported rates of good/excellent cosmesis at baseline and 6 months, 1, 2, and 3 years post-treatment as measured by the NRG cosmesis scale | September 2021 |
NCT03520894 | Recruiting | RT in preoperative setting with CyberKnife for BC | Single fraction of RT with Cyberknife Dose: a single fraction of 21 Gy. | Evaluate the safety and feasibility of single fraction RT and to identify predictive factors for outcome based on biologic and clinical parameters | Rate of acute skin toxicity events, measured according to RTOG/EORTC scale | May 1, 2022 |
NCT01717261 | Recruiting | Single Pre-Operative RT (SPORT) for low-risk BC | Single fraction Pre-Operative RT Dose: Dose escalation (15 Gy, 18 Gy, 20 Gy). | Assess if RT administered in a single preoperative fraction is tolerable in terms of acute, chronic toxicity and cosmetic outcome. Ipsilateral BC recurrence at 5 years will be assessed. | Acute toxicity and wound healing complications from the preoperative radiation treatment as per NCI CTCAE Common Toxicity Scale. | December 2019 |
NCT02316561 | Completed | Single Dose Ablative RT for Early-Stage BC | Single dose ablative PBI Dose: NS. Surgery will be performed 6 months after the ablative RT. | Investigate the feasibility, efficacy, cosmetic results, and quality of life after single dose, ablative PBI. Tumor related genetic characteristics associated with radiotherapy responsiveness will be evaluated. | pCR | April 2018, ACTUAL |
NCT02212860 | Recruiting | Stereotactic Image-Guided Neoadjuvant Ablative Radiation Then Lumpectomy (SIGNAL) | Stereotactic Body Radiation delivered in prone position, using Volumetric-modulated arc therapy (VMAT), planned on co-registered PET/MRI and CT imaging. Dose: single dose of 21 Gy, then surgery. | Assess toxicity, cosmesis and efficacy of single fraction SBRT in early stage BC. A pathologic assessment of the impact of radiation at a microscopic level and on tumor markers will be performed. | Toxicity graded according to CTCAE 4.0 | April 2018, ACTUAL |