Postoperative Radiotherapy in Breast Cancer- Concurrent or Sequential With Chemotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Chemoradiation, Chemoradiation.
- Who it may be relevant to
- Registry conditions: Invasive Breast Cancer, Stage III Breast Cancer, Stage IIB Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Phase III Randomized Controlled Trial of Sequential Chemotherapy and Radiotherapy Versus Concurrent Chemoradiotherapy in Adjuvant Treatment of Breast Cancer (CONCERT)
Overview
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.
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.
Primary outcome measures
- Study the 3-year Disease Free Survival. [Time frame: From enrollment to 3 years after treatment at six months intervals.]
Secondary outcome measures (6)
- 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.]
- 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.]
- 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.]
- 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]
- Overall survival (OS)outcome assessment in the two arms. [Time frame: 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]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
India · 5 centers
- Homi Bhabha Cancer Hospital & Research Centre — Vishkhapatnam
- Tata Memorial Centre — Mumbai
- Homi Bhabha Cancer Hospital and Research Centre — New Chandigarh
- Homi Bhabha Cancer Hospital, Sangrur — Sangrur
- Mahamana Pandit Madan Mohan Malviya Cancer Centre — Varanasi
Publications
- 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. PMID 37113709
Identifiers
NCT: NCT06926543 · 4131 · CTRI/2023/06/054280