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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Pathologically confirmed invasive breast cancer

• Stage IIB-III invasive breast cancer (AJCC 8th edition)

• Patients planned for adjuvant chemotherapy and adjuvant radiotherapy

• Patients fit to receive adjuvant chemotherapy and radiotherapy

• Age \> 18 years

Locations
Other Locations
India
Tata Memorial Centre
RECRUITING
Mumbai
Homi Bhabha Cancer Hospital and Research Centre
NOT_YET_RECRUITING
New Chandigarh
Homi Bhabha Cancer Hospital, Sangrur
NOT_YET_RECRUITING
Sangrur
Mahamana Pandit Madan Mohan Malviya Cancer Centre
NOT_YET_RECRUITING
Varanasi
Homi Bhabha Cancer Hospital & Research Centre
NOT_YET_RECRUITING
Vishkhapatnam
Contact Information
Primary
Tabassum Wadasadawala, MD, DNB Radiotherapy
drtabs.radonc@gmail.com
(+91-22) 24177026
Time Frame
Start Date: 2024-05-14
Estimated Completion Date: 2031-05
Participants
Target number of participants: 858
Treatments
Active_comparator: Arm A: Standard Arm
Participants randomized to arm A arm will receive sequential chemotherapy and radiotherapy
Experimental: Arm B: Experimental arm
Participants randomized to arm B will receive concurrent chemotherapy and radiotherapy
Related Therapeutic Areas
Sponsors
Leads: Dr. Tabassum Wadasadawala

This content was sourced from clinicaltrials.gov