Postoperative Radiotherapy in Breast Cancer- Concurrent or Sequential With Chemotherapy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorDr. Tabassum Wadasadawala
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Chemoradiation
DrugThis intervention will consist of getting chemotherapy followed by radiotherapy, i.e, in a sequential manner
Chemoradiation
DrugThis intervention will consist of getting chemotherapy and radiotherapy at the same time, i.e, in a concurrent manner.
Treatment groups
858 Participants
are divided into 2 treatment groupsGroup A: Arm A: Standard ArmActive comparator 1 intervention
Group B: Arm B: Experimental armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Study the 3-year Disease Free Survival.
Time frame
From enrollment to 3 years after treatment at six months intervals.Secondary outcomes
1
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.2
Subjective and objective assessment of cosmesis in breast-conserving surgery patients, utilizing the Harvard scale and the BCCT core photographic evaluation, respectively.
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.
Time frame
From enrollment at pre-raditherapy, post-radiotherapy completion and on follow up at 12-monthly interval up to 3 years.3
The difference in direct and indirect cost of treatment in the two arms will be assessed using the FACT-COST.
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.
Time frame
From enrollment at start of adjuvant chemotherapy, pre-radiotherapy and at post radiotherapy treatment.4
To assess the rate of lymphedema in the two arms of the trial using subjective and objective methods
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.
Time frame
From enrollment at pre-radiotherapy, post-radiotherapy completion and annually thereafter till 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Dr. Tabassum Wadasadawala
Lead sponsor
Tata Memorial Centre
Sponsor institution
Source ClinicalTrials.gov