Last reviewed · How we verify
NCT03561454
A Registry of Intra-Operative Radiation Therapy (IORT) Using the Xoft ® Axxent ® eBx ™ System Patients
trial testing IORT in Early Stage Breast Cancer in 100 participants. Participants enrolled and being followed up; not accepting new ones.
1 August 2028
Quick facts
| Lead sponsor | MedStar Franklin Square Medical Center |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 100 |
| Start date | 11 January 2019 |
| Primary completion | 1 August 2028 |
| Estimated completion | 1 August 2029 |
| Sites | 1 location across United States |
Drugs / interventions tested
- IORT
Conditions studied
- Early Stage Breast Cancer — all drugs for Early Stage Breast Cancer →
Sponsor
MedStar Franklin Square Medical Center
Who can join
Adults 40 to 100, female only, with Early Stage Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Single arm, prospective, multi-center, non-randomized study of subjects treated with single fraction, intra-operative radiation therapy at the time of lumpectomy for early stage breast cancer.To assess the rate of ipsilateral breast tumor recurrence in subjects treated with the Xoft Axxent Electronic Brachytherapy System when used for single-fraction, intra-operative radiation therapy treatment of early stage breast cancer when compared to whole breast irradiation (WBI) at 5 years of follow-up. The results of this single arm study will be compared to whole breast irradiation (WBI).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03561454
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of IORT
Trials testing the same drug.
- NCT03716531 — Electron Beam Intraoperative Radiation Therapy Following Chemoradiation in Patients With Pancreatic Cancer With Vascular · NA · active not recruiting
- NCT03536897 — IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry · recruiting
- NCT04278638 — IORT in Local Advanced Laryngocarcinoma · NA · unknown
Other recruiting trials for Early Stage Breast Cancer
Currently open trials in the same condition.
- NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting
- NCT07071038 — Evaluating the Use of a Medication 'Switch' vs Guideline-directed Interventions for Relieving Side Effects of Aromatase · Phase 2 · recruiting
- NCT04458532 — Exercise Therapy to Improve Cardiovascular Health in Post-Menopausal Women After Treatment for Early Stage Breast Cancer · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03561454 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by MedStar Franklin Square Medical Center
- Last refreshed: 19 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03561454.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing