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Postoperative Radiotherapy in Breast Cancer- Concurrent or Sequential With Chemotherapy

NCT06926543 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 858

Last updated 2025-04-13

No results posted yet for this 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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Dr. Tabassum Wadasadawala

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-14
Primary Completion
2031-05-31
Completion
2031-05-31

Countries

  • India

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06926543 on ClinicalTrials.gov