Conversion Surgery for Gastric Cancer With Peritoneal Metastases (CONVERGENCE)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The goal of this clinical trial is to evaluate the impact of conversion surgery on overall survival (OS) in patients with gastric cancer peritoneal metastases (GCPM) who show a good response to preoperative systemic therapy (including first-line chemotherapy with or without targeted therapy and/or immunotherapy) with or without peritoneal-directed chemotherapy.]. The main question it aims to answer is:
(i) Will Conversion surgery be associated with improved overall survival (OS) in patients with GCPM who respond well to preoperative systemic therapy, compared to patients who do not undergo surgery? (ii) Will Quality of life be comparable or improved in patients who undergo conversion surgery compared to patients receiving palliative chemotherapy as measured by the QLQ-C30 questionnaire?
If there is a comparison group: Researchers will compare Arm 1 (Conversion surgery with systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal directed chemotherapy) to Arm 2 (systemic therapy alone (including 1L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal directed chemotherapy) to see if the conversion surgery will be associated with improved overall survival (OS) in Arm 1.
Participants will be randomized to either Arm 1 or Arm 2.
- For Arm 1, participants will go for conversion surgery then continue systemic therapy.
- For Arm 2, participants will continue systemic therapy.
Radiological assessment will be performed every 6 months or upon progression of disease, whichever comes earlier.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •GCPM detected on surgical exploration and demonstrated by histology or cytology
- •Primary GC not resected
- •Age > 21 (or > 18 as allowed by individual institution review boards)
排除标准
- •Pregnant and lactating females
- •Prior surgical treatment for GC involving resection
- •Clinical or radiological progression during 1st line systemic treatment
研究组 & 干预措施
Conversion surgery with systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunot
干预措施: Conversion Surgery (Procedure)
systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal d
干预措施: Systemic Therapy/Standard of Care (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: From enrollment to the end of follow-up at 36 months.
Time from randomization to death from any cause. Patients alive or lost to follow-up at analysis will be censored at the date last known alive.
次要结局
- Progression-free survival (PFS)(From enrollment to the end of follow-up at 36 months.)
- Surgical outcomes(From surgery to 90 days post-operation, and up to the end of follow-up at 36 months for late events.)
- Quality of Life - Global Health Status (EORTC QLQ-C30(Baseline and scheduled follow-up visits up to 36 months.)
- Quality of Life - Gastro-Oesophageal Symptoms (EORTC QLQ-OG25)(Baseline and scheduled follow-up visits up to 36 months.)
- Quality of Life - General Health Status (EQ-5D-5L)(Baseline and scheduled follow-up visits up to 36 months.)