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Comparative study between 2 types of courses of radiotherapy in Post operative female Breast Cancer patients.

A Prospective Randomised Study To Compare The Outcome Between Conventional Radiotherapy And Hypo-Fractionated Radiotherapy Following Modified Radical Mastectomy in Female Breast Cancer Patients - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094933
Enrollment
100
Registered
2025-09-16
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: C50- Malignant neoplasm of breast

Interventions

Intervention1: Conventional Radiotherapy in Post MRM Breast Cancer patients: Arm A-50 Gy per 25 fractions,2 Gy per fraction, 1 fraction per day for 5 days in a week Control Intervention1: Hypo-fracti

Sponsors

Mudunuri Lakshmi Priyanka
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Study participants shall be selected according to the following criteria: 1. Patients with proven Histopathological report. 2. Age between 20 - 70 years. 3. Stage - T1 -T2 Node positive Disease, Any T3/above, any node positive, Post Modified Radical Mastectomy. 4.Patient with adequate Lung function, Liver function, Cardiac function, and haematological parameter.

Exclusion criteria

Exclusion criteria: 1. Any earlier chest wall radiation 2. Any Breast Conservation Surgery 3. Very early-stage node negative Breast Disease 4. H/o Any other malignancies within first 5 years of including breast cancer 5. Any uncontrolled comorbidities and collagen vascular diseases. 6. Metastatic Disease 7.Local recurrence.

Design outcomes

Primary

MeasureTime frame
a)To compare the loco regional failure between 2 arms. b)To compare acute toxicities as per RTOG/CTCAE v5.0 criteria between 2 arms. Timepoint: 18 months—

Secondary

MeasureTime frame
To compare distant disease-free survival between 2 arms.Timepoint: 18 months—

Countries

India

Contacts

Public ContactAmitabha Manna

IPGMER and SSKM HOSPITAL

amitavamanna1965@gmail.com9433009577

Outcome results

None listed

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