Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06926543

Postoperative Radiotherapy in Breast Cancer- Concurrent or Sequential With Chemotherapy

Led by Dr. Tabassum Wadasadawala · Updated on 2025-04-13

858

Participants Needed

5

Research Sites

363 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Postoperative Radiotherapy in Breast Cancer- Concurrent or Sequential With Chemotherapy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pathologically confirmed invasive breast cancer
  • Stage IIB-III invasive breast cancer (AJCC 8th edition)
  • Planned for adjuvant chemotherapy and adjuvant radiotherapy
  • Fit to receive adjuvant chemotherapy and radiotherapy
  • Age over 18 years
Not Eligible

You will not qualify if you...

  • Hypersensitivity to taxanes
  • Receiving entire chemotherapy before surgery (neoadjuvant setting)
  • Unable or unwilling to attend regular follow-up
  • Bilateral tumor requiring radiation therapy to both sides
  • Planned radiation therapy to oligometastatic sites
  • Unfavourable anatomy leading to high radiation dose to heart and/or lungs
  • Pregnant patient

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Homi Bhabha Cancer Hospital & Research Centre

Vishkhapatnam, Andhra Pradesh, India, 530053

Not Yet Recruiting

2

Tata Memorial Centre

Mumbai, Maharasthra, India, 400012

Actively Recruiting

3

Homi Bhabha Cancer Hospital and Research Centre

New Chandigarh, Punjab, India, 140901

Not Yet Recruiting

4

Homi Bhabha Cancer Hospital, Sangrur

Sangrur, Punjab, India, 148001

Not Yet Recruiting

5

Mahamana Pandit Madan Mohan Malviya Cancer Centre

Varanasi, Uttar Pradesh, India, 221005

Not Yet Recruiting

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Research Team

T

Tabassum Wadasadawala, MD, DNB Radiotherapy

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Postoperative Radiotherapy in Breast Cancer- Concurrent or Sequential With Chemotherapy | DecenTrialz