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RECRUITING
NCT06926543
PHASE3

Postoperative Radiotherapy in Breast Cancer- Concurrent or Sequential With Chemotherapy

Sponsor: Dr. Tabassum Wadasadawala

View on ClinicalTrials.gov

Summary

This clinical research aims to determine if concurrent chemotherapy and radiation therapy is more effective than sequential chemotherapy and radiation therapy for patients with stage IIB-III breast cancer. It seeks to answer the following key questions: 1. When compared to sequential treatment, does concurrent chemoradiotherapy increase disease-free survival? 2. What effects does concurrent treatment have on post-operative look, quality of life, and side effects including arm swelling (lymphoedema)? 3. What are each treatment approach's financial costs? Researchers will compare the following to groups: Arm A: Participants in the sequential treatment group will first undergo chemotherapy and then radiation. and Arm B: Participants in the concurrent treatment group will undergo radiation therapy while undergoing chemotherapy. Participants are going to: 1. Get the usual chemotherapy (taxanes and/or anthracyclines). 2. Receive radiation therapy for three to four weeks. 3. Have follow-up visits every 6months for 5years to check for cancer recurrence, side effects, and quality of life.

Official title: Phase III Randomized Controlled Trial of Sequential Chemotherapy and Radiotherapy Versus Concurrent Chemoradiotherapy in Adjuvant Treatment of Breast Cancer (CONCERT)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

858

Start Date

2024-05-14

Completion Date

2031-05

Last Updated

2025-04-13

Healthy Volunteers

No

Interventions

DRUG

Chemoradiation

This intervention will consist of getting chemotherapy followed by radiotherapy, i.e, in a sequential manner

DRUG

Chemoradiation

This intervention will consist of getting chemotherapy and radiotherapy at the same time, i.e, in a concurrent manner.

Locations (5)

Homi Bhabha Cancer Hospital & Research Centre

Vishkhapatnam, Andhra Pradesh, India

Tata Memorial Centre

Mumbai, Maharasthra, India

Homi Bhabha Cancer Hospital and Research Centre

New Chandigarh, Punjab, India

Homi Bhabha Cancer Hospital, Sangrur

Sangrur, Punjab, India

Mahamana Pandit Madan Mohan Malviya Cancer Centre

Varanasi, Uttar Pradesh, India