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Clinical Trials in India / NCT06926543
Recruiting Phase 3

Postoperative Radiotherapy in Breast Cancer- Concurrent or Sequential With Chemotherapy

NCT06926543 · tracked via the Priya Life Science India tracker
Sponsor
Dr. Tabassum Wadasadawala
Phase
Phase 3
Started
2024-05-14
Last updated
2025-04-13

Condition(s) studied

Invasive Breast CancerStage III Breast CancerStage IIB Breast Cancer

Investigational drug(s) / intervention(s)

ChemoradiationChemoradiation

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Pathologically confirmed invasive breast cancer 2. Stage IIB-III invasive breast cancer (AJCC 8th edition) 3. Patients planned for adjuvant chemotherapy and adjuvant radiotherapy 4. Patients fit to receive adjuvant chemotherapy and radiotherapy 5. Age \> 18 years Exclusion Criteria: 1. Hypersensitivity to taxanes 2. Patients receiving entire chemotherapy prior to surgery (neoadjuvant setting) 3. Unable or unwilling for regular follow up 4. Bilateral tumour needed RT to both sides 5. Patients planned for RT to oligometastatic sites 6. Unfavourable anatomical factors potentially leading to higher radiotherapy dose to heart and/or lungs (Exceeding the protocol specific mandatory dose constraints). 7. Pregnant patient

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Homi Bhabha Cancer Hospital & Research Centre Vishkhapatnam Andhra Pradesh Not Yet Recruiting
Tata Memorial Centre Mumbai Maharasthra Recruiting
Homi Bhabha Cancer Hospital and Research Centre New Chandigarh Punjab Not Yet Recruiting
Homi Bhabha Cancer Hospital, Sangrur Sangrur Punjab Not Yet Recruiting
Mahamana Pandit Madan Mohan Malviya Cancer Centre Varanasi Uttar Pradesh Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06926543 on ClinicalTrials.gov ↗ ← All trials in India