A randomised trial to compare the method of delivering chemotherapy and radiotherapy together followed by surgery with the method of doing chemotherapy followed by surgery and radiotherapy in advanced cancer of breast.

A phase III randomised trial of neoadjuvant concurrent chemoradiation followed by surgery compared to neoadjuvant chemotherapy followed by surgery and adjuvant radiotherapy in locally advanced carcinoma of breast.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/09/002029

Enrollment

100

Registered

2011-09-30

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- Locally advanced carcinoma of breast female patients

Interventions

Intervention1: Preoperative concurrent chemoradiation followed by surgery and adjuvant chemotherapy: Arm A: Concurrent NACT arm will have primary therapy with ECF (Injection Cyclophosphamide 500 mg/m2

Eligibility

Inclusion criteria

Inclusion criteria: 1.Biopsy/ FNAC proven infiltrating duct carcinoma of breast 2.Clinical Stage IIIA, IIIB, (IIIA- T0-T3, N2 M 0 stage) (IIIB- T4, N0-2, M0) 3.Non-metastatic disease 4.ECOG performance status 0-2 5.Stable cardiopulmonary reserve 6.Normal liver and renal function 7.Normal cognitive function with ability to understand the implications of study 8.Informed consent 9.No contraindications for radiotherapy/ surgery

Exclusion criteria

Exclusion criteria: 1.Prior treatment elsewhere 2.Uncontrolled co-morbidities 3.Unsure compliance 4.Poor social support and educational background to comprehend the study details and implications

Design outcomes

Primary

Measure	Time frame
Overall SurvivalTimepoint: 1,2,3,4,5 years	—

Secondary

Measure	Time frame
Cardiac and pulmonary toxicityTimepoint: 0,6months,1,2,3,4,5;Disease Free survivalTimepoint: 1,2,3,4,5	—

Countries

India

Contacts

Public ContactDr Milind Kumar

Malabar cancer centre Thalassery

drmilindkumar@yahoo.com9656830039

Outcome results

None listed

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