Postoperative Radiotherapy in Breast Cancer- Concurrent or Sequential With Chemotherapy
NCT ID: NCT06926543
Last Updated: 2025-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
858 participants
INTERVENTIONAL
2024-05-14
2031-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Standard Arm
Participants randomized to arm A arm will receive sequential chemotherapy and radiotherapy
Chemoradiation
This intervention will consist of getting chemotherapy followed by radiotherapy, i.e, in a sequential manner
Arm B: Experimental arm
Participants randomized to arm B will receive concurrent chemotherapy and radiotherapy
Chemoradiation
This intervention will consist of getting chemotherapy and radiotherapy at the same time, i.e, in a concurrent manner.
Interventions
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Chemoradiation
This intervention will consist of getting chemotherapy followed by radiotherapy, i.e, in a sequential manner
Chemoradiation
This intervention will consist of getting chemotherapy and radiotherapy at the same time, i.e, in a concurrent manner.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Dr. Tabassum Wadasadawala
OTHER
Responsible Party
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Dr. Tabassum Wadasadawala
Professor and Radiation oncologist
Locations
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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
Countries
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Central Contacts
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Tabassum Wadasadawala, MD, DNB Radiotherapy
Role: CONTACT
Facility Contacts
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References
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Wadasadawala T, Anup A, Carlton J, Sarin R, Gupta S, Parmar V, Pathak R, Ghosh J, Bajpai J, Gulia S, Krishnamurthy R. CONcurrent ChEmotherapy and RadioTherapy in adjuvant treatment of breast cancer (CONCERT): a phase 2 study. Ecancermedicalscience. 2023 Feb 23;17:1510. doi: 10.3332/ecancer.2023.1510. eCollection 2023.
Related Links
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A Pilot Study of CONcurrent ChEmotherapy and RadioTherapy in Adjuvant Treatment of Breast Cancer (CONCERT)
Other Identifiers
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CTRI/2023/06/054280
Identifier Type: REGISTRY
Identifier Source: secondary_id
4131
Identifier Type: -
Identifier Source: org_study_id
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