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Intraoperative radiotherapy during breast cancer surgery

Results of intraoperative radiotherapy as a boost in non-metastatic breast cancer undergoing breast conservation surgery

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20191123045474N1
Enrollment
50
Registered
2019-11-26
Start date
2019-12-13
Completion date
Unknown
Last updated
2019-12-17

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

Conditions

Breast cancer. Malignant neoplasm of breast

Interventions

Intervention group: During breast-conserving surgery, patients will be treated with INTRABEAM 50-kV X-ray source at a dose of 20 Gy. Postoperatively, patients will receive systemic treatment according

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
35 Years to 65 Years

Inclusion criteria

Inclusion criteria: Pathologic diagnosis of invasive ductal breast cancer Breast cancer with size less than or equal to 3 cm No lymph node involvement No distant metastases

Exclusion criteria

Exclusion criteria: Pregnancy Lactation Active collagen vascular diseases such as scleroderma Previous radiotherapy in diseases such as Hodgkin's lymphoma Multifocal breast cancer Presence of distant metastasis

Design outcomes

Primary

MeasureTime frame
Disease free survival. Timepoint: Two years after completion of treatment. Method of measurement: Physical examination and breast imaging.;Overall survival. Timepoint: Two years after completion of treatment. Method of measurement: Follow up of patient.;Skin toxicity. Timepoint: Two years after completion of treatment. Method of measurement: Physical examination based on toxicity criteria of the Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer.;Subcutaneous toxicity. Timepoint: Two years after completion of treatment. Method of measurement: Physical examination based on toxicity criteria of the Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactElyar Mousa Pour Shahi

Mashhad University of Medical Sciences

MousapourSE951@mums.ac.ir+98 51 3842 6936

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026