Postoperative Radiotherapy in Breast Cancer- Concurrent or Sequential With Chemotherapy

Last updated: April 7, 2025
Sponsor: Dr. Tabassum Wadasadawala
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Chemoradiation

Clinical Study ID

NCT06926543
4131
CTRI/2023/06/054280
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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

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 toheart and/or lungs (Exceeding the protocol specific mandatory dose constraints).

  7. Pregnant patient

Study Design

Total Participants: 858
Treatment Group(s): 1
Primary Treatment: Chemoradiation
Phase: 3
Study Start date:
May 14, 2024
Estimated Completion Date:
May 31, 2031

Connect with a study center

  • Homi Bhabha Cancer Hospital & Research Centre

    Vishkhapatnam, Andhra Pradesh 530053
    India

    Site Not Available

  • Tata Memorial Centre

    Mumbai, Maharasthra 400012
    India

    Active - Recruiting

  • Homi Bhabha Cancer Hospital and Research Centre

    New Chandigarh, Punjab 140901
    India

    Site Not Available

  • Homi Bhabha Cancer Hospital, Sangrur

    Sangrur, Punjab 148001
    India

    Site Not Available

  • Mahamana Pandit Madan Mohan Malviya Cancer Centre

    Varanasi, Uttar Pradesh 221005
    India

    Site Not Available

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