NCT02751710已完成不适用
Impact of 18F-FDG PET-CT Versus Conventional Staging in the Management of Patients Presenting With Clinical Stage III Breast Cancer
Ontario Clinical Oncology Group (OCOG)12 个研究点 分布在 1 个国家目标入组 369 人开始时间: 2016年12月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 369
- 试验地点
- 12
- 主要终点
- Proportion of patients upstaged to Stage IV disease
研究概览
简要总结
This trial is being conducted to determine the impact of whole body FDG PET-CT vs. conventional staging in the management of patients presenting with clinical Stage III breast cancer. Eligible consenting patients with ductal or mixed histology breast cancer will be randomized 1:1 to whole body FDG PET-CT or conventional staging. Eligible consenting patients with lobular only histology will be entered into a separate single arm prospective study and will undergo whole body FDG PET-CT, CT with contrast of the chest/abdomen & pelvis and a bone scan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Women (or men) with histological evidence of breast cancer for whom potentially curative treatment is planned.
- •Based on clinical information (physical exam, imaging):
- •Stage III breast cancer (T0N2, T1N2, T2N2, T3N1, 2 or T4), or
- •Stage IIb breast cancer (T3N0), Note: T2N1 is not eligible
- •Considered for combined modality therapy (surgical resection, chemotherapy, radiotherapy) of curative intent.
排除标准
- •Age < 18 years,
- •ECOG performance status > and = 3,
- •Prior systemic therapy (e.g. neo-adjuvant chemotherapy or hormonal therapy) for current breast cancer,
- •Previous staging investigations for current breast cancer,
- •Breast cancer with primary histological subtypes other than ductal or lobular (Note: Patients with mixed disease will be eligible for randomization),
- •Clinical suspicion of metastatic disease,
- •Relative contraindications to PET (e.g. uncontrolled diabetes (i.e. inability to decrease serum glucose below 10.2 mmol/L), claustrophobia, inability to be still for 30 minutes),
- •Inability to lie supine for imaging with PET-CT,
- •Inability to undergo CT because of known allergy to contrast,
- •History of another invasive malignancy within the previous two years (exception of non melanoma skin cancer) or a synchronous primary cancer, including a synchronous contralateral breast cancer (Note: Patients found to have a contralateral breast cancer on study imaging following randomization will remain in the study),
- •Known pregnancy or lactating female,
- •Inability to complete the study or required follow-up.
结局指标
主要结局
Proportion of patients upstaged to Stage IV disease
时间窗: Within 30 days from date of randomization
Proportion of patients upstaged to Stage IV disease as a result of the imaging study, between the groups
次要结局
- Prognostic ability of PET SUV of the primary lesion on the pathological response rate to neo-adjuvant chemotherapy(Within 12 months from date of randomization)
- Disease Free Survival(From date of randomization to date of event, assessed up to 5 years)
- Number of additional tests, such as imaging and biopsy, resulting from findings of study imaging(Within 12 months from date of randomization)
- Proportion of patients who receive multimodal therapy of curative intent(Within 12 months from date of randomization)
- Overall Survival(From date of randomization to date of event, assessed up to 5 years)
- Incremental economic analysis comparing the costs and outcomes of the treatment arms(Within 5 years from date of randomization)
研究者
研究点 (12)
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