Effect of radiotherapy time in breast cancer

Comparison of the effectiveness of neoadjuvant with adjuvant radiotherapy in patients with early breast cancer

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180919041070N1

Enrollment

120

Registered

2019-04-04

Start date

2019-01-21

Completion date

Unknown

Last updated

2019-04-23

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 1: Intervention group: A group that received neoadjuvant radiation therapy (50 Gy in 25 fraction) and boost dose during surgery (12 Gy IORT)? then receive surgery, chemotherapy, and hormo

then they receive hormone therapy. Intervention 4: Control group: A group that is undergoing surgery and chemotherapy, then receive adjuvant radiation therapy (50 Gy in 25 fraction) and conventional b

then they receive hormone therapy.

Eligibility

Sex/Gender

Female

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Women with breast cancer with stage T1-T2 / N0 / M0, which have ER + and HER2-- Candidate for Radiation Therapy For the first time, they have had cancer age between 18 to 70 years

Exclusion criteria

Exclusion criteria: Earlier history of radiation therapy

Design outcomes

Primary

Measure	Time frame
Cancer free survival. Timepoint: Every 3 months until two years. Method of measurement: absence of recurrence disease based on examination and ultrasound and mammography.;Acute skin toxicity due to radiation therapy. Timepoint: Weekly evaluation during radiotherapy and then 4 and 12 weeks after radiotherapy. Method of measurement: Based on acute radiation dermatitis common toxicity criteria.;Late skin toxicity due to radiation therapy. Timepoint: 6 months after radiotherapy and then every 3 months until one year. Method of measurement: Using the RTOG/EORTC radiation morbidity scoring scheme.;Cosmetic results. Timepoint: Six months after radiotherapy and then every 6 months until 2 years. Method of measurement: RTOG (4 point scoring system), LENT-SOMA score and BCCT software.;Surgical complications including infection, not wound healing & seroma. Timepoint: After two weeks of surgery. Method of measurement: History,inspection location of ulcer and examination, and ultrasound to estimate the amount of seruma.	—

Measure

Time frame

Cancer free survival. Timepoint: Every 3 months until two years. Method of measurement: absence of recurrence disease based on examination and ultrasound and mammography.;Acute skin toxicity due to radiation therapy. Timepoint: Weekly evaluation during radiotherapy and then 4 and 12 weeks after radiotherapy. Method of measurement: Based on acute radiation dermatitis common toxicity criteria.;Late skin toxicity due to radiation therapy. Timepoint: 6 months after radiotherapy and then every 3 months until one year. Method of measurement: Using the RTOG/EORTC radiation morbidity scoring scheme.;Cosmetic results. Timepoint: Six months after radiotherapy and then every 6 months until 2 years. Method of measurement: RTOG (4 point scoring system), LENT-SOMA score and BCCT software.;Surgical complications including infection, not wound healing & seroma. Timepoint: After two weeks of surgery. Method of measurement: History,inspection location of ulcer and examination, and ultrasound to estimate the amount of seruma.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactPedram Fadavi

Iran University of Medical Sciences

Fadavi.p@iums.ac.ir+98 21 5522 8580

Outcome results

None listed

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