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| ID | Type | Description | Link |
|---|---|---|---|
| CTRI/2023/06/054280 | Registry Identifier | Clinical Trials Registry - India (ICMR-NIMS) |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Standard Arm | Active Comparator | Participants randomized to arm A arm will receive sequential chemotherapy and radiotherapy |
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| Arm B: Experimental arm | Experimental | Participants randomized to arm B will receive concurrent chemotherapy and radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemoradiation | Drug | This intervention will consist of getting chemotherapy followed by radiotherapy, i.e, in a sequential manner |
|
| Measure | Description | Time Frame |
|---|---|---|
| Study the 3-year Disease Free Survival. | From enrollment to 3 years after treatment at six months intervals. |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of concurrent regimen on patient's Quality of life using the EORTC QLQ 30 and BR 23 and EQ5D5L questionnaire. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tabassum Wadasadawala, MD, DNB Radiotherapy | Contact | (+91-22) 24177026 | 7026 | drtabs.radonc@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Homi Bhabha Cancer Hospital & Research Centre | Not yet recruiting | Vishkhapatnam | Andhra Pradesh | 530053 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37113709 | Background | 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. |
| Label | URL |
|---|---|
| A Pilot Study of CONcurrent ChEmotherapy and RadioTherapy in Adjuvant Treatment of Breast Cancer (CONCERT) | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
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| Chemoradiation | Drug | This intervention will consist of getting chemotherapy and radiotherapy at the same time, i.e, in a concurrent manner. |
|
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. |
| 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. | 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. | 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 | 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. | From enrollment at pre-radiotherapy, post-radiotherapy completion and annually thereafter till 3 years |
| Overall survival (OS)outcome assessment in the two arms. | From enrollment to 5 years after treatment at 6 months intervals |
| Breast Cancer Specific Survival (BCSS) will be assessed with regular follow-ups. | From enrollment to 5 years after treatment at 6 months intervals |
| Tata Memorial Centre | Recruiting | Mumbai | Maharasthra | 400012 | India |
|
| Homi Bhabha Cancer Hospital and Research Centre | Not yet recruiting | New Chandigarh | Punjab | 140901 | India |
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| Homi Bhabha Cancer Hospital, Sangrur | Not yet recruiting | Sangrur | Punjab | 148001 | India |
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| Mahamana Pandit Madan Mohan Malviya Cancer Centre | Not yet recruiting | Varanasi | Uttar Pradesh | 221005 | India |
|
| D017437 |
| Skin and Connective Tissue Diseases |