A clinical trial to study the effects of two radiotherapy schedules, conventional and hypofractionated, following mastectomy operation in female breast cancer patients with locally advanced disease

A RANDOMISED PROSPECTIVE STUDY COMPARING THE EFFICACY AND ACCEPTABILITY OF HYPOFRACTIONATED SCHEDULE VS CONVENTIONAL SCHEDULE OF ADJUVANT RADIOTHERAPY IN FEMALE BREAST CANCER - HFRT in LABC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/04/013174

Enrollment

Registered

2018-04-11

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Adjuvant Radiotherapy in Female Breast Cancer Patients

Interventions

Intervention1: Hypofractionated Radiotherapy: 40 Gy in 15 fractions over 3 weeks at 267 cGy per fraction daily Control Intervention1: Conventional Radiotherapy: 50 Gy in 25 fractions over 5 weeks at 2

Eligibility

Inclusion criteria

Inclusion criteria: Female patients with histologically confirmed invasive breast cancer, who underwent modified radical mastectomy and planned for adjuvant radiotherapy as per Institutional Tumour Board decision Patients tumours with pathological stage IIA-IIIC Any patient who had received neoadjuvant chemotherapy Patients with normal haematological, cardiac and pulmonary functions prior to radiotherapy Patients must provide study specific informed consent prior to study entry.

Exclusion criteria

Exclusion criteria: Patients with clinical N3 disease with metastatic supraclavicuar lymphadenopathy Patients with Stage IV metastatic disease Patients with tangential beam margins separation more than 22 cm Patients with non-epithelial malignancies Patients with co-existent or previous history of other malignancy Patients who received prior radiotherapy to chest wall region Patients with severe physical or mental co-morbidities

Design outcomes

Primary

Measure	Time frame
To evaluate safety of Hypofractionated Radiotherapy in terms of radiation induced normal tissue toxicities compared to Conventional FractionationTimepoint: 4 years	—

Secondary

Measure	Time frame
To compare effectiveness of Hypofractionated Radiotherapy to Conventional Fractionation by evaluating Overall Survival (OS) and Disease Free Survival (DFS) ratesTimepoint: 4 years	—

Countries

India

Contacts

Public ContactDr Partha Pratim Medhi

Dr. Bhubaneswar Borooah Cancer Inxtitute

parthapmedhi88@gmail.com8399815602

Outcome results

None listed

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