A Phase 2 Randomized, Open-label, Single-center study of Accelerate Partial Breast Irradiation using Robotic System versus MR-Linac: Toxicity Assessment (RobotMR trial)

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250110002

Enrollment

206

Registered

2025-01-10

Start date

2023-12-21

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early stage breast cancer Breast Neoplasms

Interventions

MR-Linac generates realtime MRI images during radiotherapy treatment, allowing target adaptive before treatment in every frac on. ,Robotic system used realtime tracking with fiducial implantation.

Experimental Radiation,Active Comparator Radiation

MR Linac,Robotic system

Eligibility

Sex/Gender

Female

Age

50 Years to 99 Years

Inclusion criteria

Inclusion criteria: Women with histologically confirmed invasive breast cancer, who underwent breast conserva ve surgery with axillary lymph node biopsy or axillary lymph node dissec on and meet suitable criteria.

Exclusion criteria

Exclusion criteria: bilateral breast cancer patient multiple primary malignancies (except for basal cell carcinoma and premalignant lesion of gynecological cancer (CIN, HSIL, LSIL, VIN, VAIN)) prior chest radiation progression of the disease before radiation unable to perform MRI

Design outcomes

Primary

Measure	Time frame
Acut skin toxicity 24 months RTOG grading system	—

Secondary

Measure	Time frame
Cosmetic outcome 24 months the four-category Harvard/US Radiation Therapy Oncology Group grading scale,Ipsilateral breast tumor recurrence 24 months Clinical and imaging criteria	—

Countries

Thailand

Contacts

Public ContactJiraporn Setakornnukul

Faculty of Medicine, Siriraj Hospital

jiraporn.set@mahidol.ac.th024197229

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026