NCT06926543招募中3 期
Phase III Randomized Controlled Trial of Sequential Chemotherapy and Radiotherapy Versus Concurrent Chemoradiotherapy in Adjuvant Treatment of Breast Cancer (CONCERT)
Dr. Tabassum Wadasadawala5 个研究点 分布在 1 个国家目标入组 858 人开始时间: 2024年5月14日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 858
- 试验地点
- 5
- 主要终点
- Study the 3-year Disease Free Survival.
研究概览
简要总结
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:
- When compared to sequential treatment, does concurrent chemoradiotherapy increase disease-free survival?
- What effects does concurrent treatment have on post-operative look, quality of life, and side effects including arm swelling (lymphoedema)?
- 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:
- Get the usual chemotherapy (taxanes and/or anthracyclines).
- Receive radiation therapy for three to four weeks.
- Have follow-up visits every 6months for 5years to check for cancer recurrence, side effects, and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm B: Experimental arm
Experimental
Participants randomized to arm B will receive concurrent chemotherapy and radiotherapy
干预措施: Chemoradiation (Drug)
Arm A: Standard Arm
Active Comparator
Participants randomized to arm A arm will receive sequential chemotherapy and radiotherapy
干预措施: Chemoradiation (Drug)
结局指标
主要结局
Study the 3-year Disease Free Survival.
时间窗: From enrollment to 3 years after treatment at six months intervals.
次要结局
- 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.(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.(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(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)
研究者
Dr. Tabassum Wadasadawala
Professor and Radiation oncologist
Tata Memorial Centre
研究点 (5)
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