RecruitingPhase 3NCT06926543

Postoperative Radiotherapy in Breast Cancer- Concurrent or Sequential With Chemotherapy

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


Sponsor

Dr. Tabassum Wadasadawala

Enrollment

858 participants

Start Date

May 14, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • 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

Exclusion Criteria7

  • Hypersensitivity to taxanes
  • Patients receiving entire chemotherapy prior to surgery (neoadjuvant setting)
  • Unable or unwilling for regular follow up
  • Bilateral tumour needed RT to both sides
  • Patients planned for RT to oligometastatic sites
  • Unfavourable anatomical factors potentially leading to higher radiotherapy dose to heart and/or lungs (Exceeding the protocol specific mandatory dose constraints).
  • Pregnant patient

Interventions

DRUGChemoradiation

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

DRUGChemoradiation

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

View Full Details on ClinicalTrials.gov

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NCT06926543


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