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Results and complications of intraoperative radiotherapy as boost after neoadjuvant chemotherapy

A clinical trial evaluating the results and complications of intraoperative radiotherapy as boost after neoadjuvant chemotherapy in patients with nonmetastatic breast cancer candidate for breast conserving surgery

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2017091428815N2
Enrollment
20
Registered
2017-09-28
Start date
2017-02-09
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Breast cancer. Breast, unspecified

Interventions

a detectable marker will be inserted under the guide of sonography in the tumor. Afterwards, the patients will receive neoadjuvant chemotherapy based on the standards of the treating institute. Before
Treatment - Devices

Sponsors

Vice-chancellery for Research of Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
30 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Women between 30 and 70 years old; informed consent for participation; pathologic confirmation of invasive ductal carcinoma of breast; tumor stages of T3N1M0, T3N0M0, T2N1M0, and T2N0M0 based on classification of American Joint Committee on Cancer; and operable breast cancer patient who is candidate for breast conserving surgery. Exclusion criteria: Pregnancy and breast feeding; active collagen vascular diseases like scleroderma; history of chest wall radiotherapy for Hodgkin lymphoma; multifocal breast cancer in two separate quadrants of breast; presence of metastasis during treatment; and poor clinical response to the neoadjuvant chemotherapy.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Two-year disease-free survival. Timepoint: every 3 months. Method of measurement: physical examination and mammography.

Secondary

MeasureTime frame
Dermatitis. Timepoint: every 3 months in the first two years; every 6 months in the third to fifth years after intervention. Method of measurement: physical examination.;Skin necrosis. Timepoint: every 3 months in the first two years; every 6 months in the third to fifth years after intervention. Method of measurement: physical examination.;Beauty. Timepoint: every 3 months in the first two years; every 6 months in the third to fifth years after intervention. Method of measurement: physical examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Alireza Keramati

Omid Hospital

keramatia941@mums.ac.ir+98 51 3842 6083

Outcome results

None listed

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