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Postoperative Radiotherapy in Breast Cancer- Concurrent or Sequential With Chemotherapy
Sponsor: Dr. Tabassum Wadasadawala
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
Chemoradiation
This intervention will consist of getting chemotherapy followed by radiotherapy, i.e, in a sequential manner
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