A Phase II Trial to Analyze Clinical and Pharmacological Properties for Severe Neutropenia After Cytoreductive Surgery Followed by Hyperthermic Intraperitoneal Chemotherapy Using Mitomycin-C
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Association between the concentration of intraoperative mitomycin-C absoprtion and severe neutropenia after CRS/HIPEC
研究概览
简要总结
Mitomycin-C (MMC) is the most commonly used chemotherapeutic agent for hyperthermic intraperitoneal chemotherapy (HIPEC) after cytoreductive surgery (CRS) to treat colorectal cancer patients with peritoneal metastases. However, MMC has a side effect of myelosuppression. Particularly, severe neutropenia after CRS with HIPEC can be a life-threatening condition. Despite the postoperative risks of this side effect, the causes and risk factors for severe neutropenia after CRS followed by HIPEC is not identified so far. Therefore, in this study, we aimed to evaluate to evaluate clinical risk factors and pharmacologic properties after CRS with HIPEC using MMC in patients with colorectal cancer or appendiceal mucinous neoplasms with peritoneal metastases.
详细描述
Evaluation parameters
- Preoperative period
- Obtaining informed consent
- Assessment of baseline clinical characteristics: vital sign, BMI, BSA, ASA classification, ECOG, CBC, CEA level
- Before 1 day of surgery, assessment of QoR-40 questionnaires
- Intra-operative period
-
CRS / HIPEC
-
Assessment for peritoneal cancer index, complete cytoreduction score
-
HIPEC procedures: HIPEC was performed using MMC 35 mg/m2 at 41-43℃ for 90 min. Following the HIPEC triple method, MMC 35 mg/m2 was mixed with 3L of Physioneal PD-2 1.5% peritoneal dialysis solution and administered into the intraperitoneal cavity at 50% of the dose at the beginning of HIPEC, 25% of the dose at 30 min, and 25% of the dose at 60 min.
-
Intraoperative samplings of blood and peritoneal fluids during HIPEC :
-
Blood sampling of 5 ml at each time point (baseline, 0 (HIPEC starting point), 15, 30, 45, 60, 75, 90, 120 min)
-
Peritoneal fluid sampling of 5 ml at each time point (baseline, 0 (HIPEC starting point), 15, 30, 45, 60, 75, 90 min)
- Postoperative period : Postoperative assessment until the discharge date or postoperative 14th days.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Joined the study voluntarily and signed informed consent form
- •Patients who diagnosed colorectal cancer or appendiceal mucinous neoplasm with peritoneal metastases
- •Patients who undergo CRS/HIPEC using MMC
- •Exclusion Criteria
- •Patients who received synchronous operations for liver or lung metastatic sites during CRS/HIPEC
- •Previous histories who underwent CRS/HIPEC
- •Patients who received palliative 3rd line chemotherapy
- •Patients who received chemotherapy within 1 year to treat other cancers
- •Patients who had PCD cathethers for ascites control
- •Infectious status
- •Age<19 years old
- •Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
- •Drop-out criteria
- •Hospital stay > 30 days
排除标准
- 未提供
结局指标
主要结局
Association between the concentration of intraoperative mitomycin-C absoprtion and severe neutropenia after CRS/HIPEC
时间窗: 2 weeks after the discharge
Comparison of the pharmacologic association between occurrence of postoperative severe neutropenia, and blood absoprtion rates of MMC and the area-under-the curve (AUC) ratios during HIPEC
次要结局
- Incidence of severe neutropenia(During 2 weeks after CRS/HIPEC)
- Changes of CEA level(During 2 weeks after CRS/HIPEC)
- Postoperative complications(During 2 weeks after CRS/HIPEC)
- Frequency of postoperative uses for G-CSF(During 2 weeks after CRS/HIPEC)
- Patterns of perioperative changes of WBC, Hemoglobin, platelet, lymphocyte, neutrophil counts(During 2 weeks after CRS/HIPEC)
- Quality of Life: QoR-40 questionnaire(During 2 weeks after CRS/HIPEC)
研究者
Eun Jung Park
Assistant Professor
Gangnam Severance Hospital