The outcomes of hypo fractionated radiotherapy in breast cancer patients

Comparing toxicity and cosmetic outcome of conventional and hypo fractionated radiotherapy with or without boost in breast cancer patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2014102519675N1

Enrollment

100

Registered

2015-06-14

Start date

2014-06-22

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. malignant neoplasm of breast

Interventions

Intervention 1: Intervention: hypo fractionated radiotherapy with boost: 42.5 Gy total dose to breast using 2.66 Gy per fraction in 22 days with 6 MV photons with 2 to 2.5 Gy per fraction electron

Treatment - Other

Intervention: hypo fractionated radiotherapy with boost: 42.5 Gy total dose to breast using 2.66 Gy per fraction in 22 days with 6 MV photons with 2 to 2.5 Gy per fraction electron boost in 4 frac

Intervention: hypo fractionated radiotherapy without boost: 42.5 Gy total dose to breast using 2.66 Gy per fraction in 22 days with 6 MV photons without electron boost

Control: standard breast radiotherapy: 50 Gy total dose to breast using 2 Gy per fraction in 35 days with 6 MV photons with 2 to 2.5 Gy per fraction electron boost in 4 fractions

Eligibility

Sex/Gender

Female

Age

20 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: patients with early stage breast cancer (T1-T2 N0) below 70 years old who have undergone breast conserving surgery and fill in the informed consent. Exclusion criteria: history of collagen vascular disease; field separation more than 22Cm; ejection fraction less than 50%; lost in follow up.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Skin toxicity. Timepoint: Every week during intervention then every two weeks in the first month after intervention and then every 3 months up to 2 years. Method of measurement: Based on NCCI Common Toxicity Criteria (CTC) version 20.;Cardiac toxicity. Timepoint: Before intervension and 4 months after intervention. Method of measurement: Echocardiography.;Lung toxicity. Timepoint: Before intervention , 6 and 12 months after intervention. Method of measurement: Spirometry.	—

Measure

Time frame

Skin toxicity. Timepoint: Every week during intervention then every two weeks in the first month after intervention and then every 3 months up to 2 years. Method of measurement: Based on NCCI Common Toxicity Criteria (CTC) version 20.;Cardiac toxicity. Timepoint: Before intervension and 4 months after intervention. Method of measurement: Echocardiography.;Lung toxicity. Timepoint: Before intervention , 6 and 12 months after intervention. Method of measurement: Spirometry.

—

Secondary

Measure	Time frame
Cosmetic outcome. Timepoint: 2 years after intervention. Method of measurement: Based on Harvard Criteria.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSare Hosseini

Mashhad University of Medical Sciences

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

Outcome results

None listed

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