Postoperative Radiotherapy in Breast Cancer- Concurrent or Sequential With Chemotherapy (CONCERT)

April 7, 2025 updated by: Dr. Tabassum Wadasadawala

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

858

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Tabassum Wadasadawala, MD, DNB Radiotherapy
  • Phone Number: 7026 (+91-22) 24177026
  • Email: drtabs.radonc@gmail.com

Study Locations

  • India
    • Andhra Pradesh
      • Vishkhapatnam, Andhra Pradesh, India, 530053
        • Not yet recruiting
        • Homi Bhabha Cancer Hospital & Research Centre
        • Contact:
        • Contact:
          • Rohit Vadgaonkar
    • Maharasthra
      • Mumbai, Maharasthra, India, 400012
        • Recruiting
        • Tata Memorial Centre
        • Contact:
        • Contact:
          • Tabassum Wadasadawala, MD, DNB (Radiotherapy)
        • Contact:
          • Rajiv Sarin, MD, DNB (Radiation oncology)
        • Contact:
          • Rima Pathak, MD (Radiotherapy)
        • Contact:
          • Revathy Krishnamurthy, MD (Radiotherapy)
        • Contact:
          • Sudeep Gupta, MD, DM (Medical oncology)
        • Contact:
          • Seema Gulia, MD, DM (Medical oncology)
        • Contact:
          • Sushmita Rath, MD, DM (Medical oncology)
        • Contact:
          • Shalaka Joshi, MS, DNB (General Surgery)
        • Contact:
          • Anuradha Daptardar, Bsc (Physiotherapy)
    • Punjab
      • New Chandigarh, Punjab, India, 140901
        • Not yet recruiting
        • HOMI BHABHA CANCER HOSPITAL AND RESEARCH CENTRE
        • Contact:
        • Contact:
          • Pragyat Thakur
      • Sangrur, Punjab, India, 148001
        • Not yet recruiting
        • Homi Bhabha Cancer Hospital, Sangrur
        • Contact:
        • Contact:
          • Jayashree Deshmukh
    • Uttar Pradesh
      • Varanasi, Uttar Pradesh, India, 221005
        • Not yet recruiting
        • Mahamana Pandit Madan Mohan Malviya Cancer Centre
        • Contact:
        • Contact:
          • Lincoln Pujari

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm A: Standard Arm
Participants randomized to arm A arm will receive sequential chemotherapy and radiotherapy
Drug: Chemoradiation
This intervention will consist of getting chemotherapy followed by radiotherapy, i.e, in a sequential manner
Drug: Chemoradiation
This intervention will consist of getting chemotherapy and radiotherapy at the same time, i.e, in a concurrent manner.
Experimental: Arm B: Experimental arm
Participants randomized to arm B will receive concurrent chemotherapy and radiotherapy
Drug: Chemoradiation
This intervention will consist of getting chemotherapy followed by radiotherapy, i.e, in a sequential manner
Drug: Chemoradiation
This intervention will consist of getting chemotherapy and radiotherapy at the same time, i.e, in a concurrent manner.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Study the 3-year Disease Free Survival.
Time Frame: From enrollment to 3 years after treatment at six months intervals.
From enrollment to 3 years after treatment at six months intervals.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of concurrent regimen on patient's Quality of life using the EORTC QLQ 30 and BR 23 and EQ5D5L questionnaire.
Time Frame: From enrollment at pre-raditherapy, post-radiotherapy completion and on follow up at 12-monthly interval up to 3 years.
From enrollment at pre-raditherapy, post-radiotherapy completion and on follow up at 12-monthly interval up to 3 years.
Subjective and objective assessment of cosmesis in breast-conserving surgery patients, utilizing the Harvard scale and the BCCT core photographic evaluation, respectively.
Time Frame: From enrollment at pre-raditherapy, post-radiotherapy completion and on follow up at 12-monthly interval up to 3 years.
All patients who undergo breast conservation surgery will be eligible for this sub-study in which we intend to collect frontal breast photographs for objective assessment of breast cosmesis.
From enrollment at pre-raditherapy, post-radiotherapy completion and on follow up at 12-monthly interval up to 3 years.
The difference in direct and indirect cost of treatment in the two arms will be assessed using the FACT-COST.
Time Frame: From enrollment at start of adjuvant chemotherapy, pre-radiotherapy and at post radiotherapy treatment.
As patients in the intervention arm will complete their treatment at least 6-8 weeks before the patients in the standard arm, it will have huge impact on the expenditure that the patient bears for staying, food as well as transport to the hospital. Hence, we would like to collect data pertaining to patient's daily expenditure during their adjuvant treatment.
From enrollment at start of adjuvant chemotherapy, pre-radiotherapy and at post radiotherapy treatment.
To assess the rate of lymphedema in the two arms of the trial using subjective and objective methods
Time Frame: From enrollment at pre-radiotherapy, post-radiotherapy completion and annually thereafter till 3 years
As the breast cancer treatment increases the risk of swelling in the upper limb, we would like to assess for the same. This will help us to diagnose lymphedema at an early stage and will be able to treat it more effectively.
From enrollment at pre-radiotherapy, post-radiotherapy completion and annually thereafter till 3 years
Overall survival (OS)outcome assessment in the two arms.
Time Frame: From enrollment to 5 years after treatment at 6 months intervals
From enrollment to 5 years after treatment at 6 months intervals
Breast Cancer Specific Survival (BCSS) will be assessed with regular follow-ups.
Time Frame: From enrollment to 5 years after treatment at 6 months intervals
From enrollment to 5 years after treatment at 6 months intervals

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Tabassum Wadasadawala

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2024

Primary Completion (Estimated)

May 1, 2031

Study Completion (Estimated)

May 1, 2031

Study Registration Dates

First Submitted

February 14, 2025

First Submitted That Met QC Criteria

April 7, 2025

First Posted (Actual)

April 13, 2025

Study Record Updates

Last Update Posted (Actual)

April 13, 2025

Last Update Submitted That Met QC Criteria

April 7, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4131
  • CTRI/2023/06/054280 (Registry Identifier: Clinical Trials Registry - India (ICMR-NIMS))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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