Phase II Multicentric Exploratory Single Cohort Clinical Trial to Assess Efficacy and Safety on a New Treatment Scheme by Systemic and Peritoneal Chemotherapy Plus Cytoreduction and HIPEC Plus Adjuvant Treatment in Patients With Peritoneal Carcinomatosis From Gastric Cancer
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- disease free survival
研究概览
简要总结
Implementation of a curative strategy of treatment in peritoneal carcinomatosis of gastric cancer. The goal is to get 1C level of evidence (patient died with "standard" treatment, with this treatment some of them survive) in terms of disease free survival and overall survival.
Methodology: prospective, phase II, multicentric in Spain. Recruitment of 50 patients(to have 31 on treatment) in three years. This strategy is based on neoadjuvant systemic plus simultaneous intraperitoneal and intravenous chemotherapy(NIPS),to treat peritoneal disease by bi-directional approach; next step is cytoreductive surgery and HIPEC. Once patients are discharged, they will follow a systemic adjuvant chemotherapy protocol.
详细描述
Patients with peritoneal carcinomatosis with gastric cancer who meet all inclusion criteria(and none of exclusion) will follow the next treatment scheme(40 week period of treatment):
Phase I (after one week of peritoneal catheter implant; total treatment 5-8 weeks): intraperitoneal infusion of Docetaxel(30 mg/m2) and Cisplatin (30mg/m2) in 1000 cc of saline. Intravenous administration 5-FU (200 mg/m2/Day, 7 days a week for 2 weeks) simultaneously with 2 cycles of Intraperitoneal administration.
These patients receive between four and six cycles of NIPS. Until phase II 4-6 weeks.
Phase II:cytoreduction (CR) plus HIPEC (total treatment 4 weeks). Maximal efforts to optimum cytoreduction.
HIPEC: intraperitoneal administration: Mytomicin C (15mg/m2)plus Adriamycin (15mg/m2) at 42-43ºC for 60 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18-65 years old
- •Histological Evidence of peritoneal carcinomatosis from gastric cancer
- •No distance metastasis
- •ECOG 0-1-2
- •No contraindication for complex surgery
- •no other malign disease except skin cancer (different from melanoma or cervix cancer CIN III)
- •willing to consent and sign ICF.
排除标准
- •No Histological Evidence of peritoneal carcinomatosis from gastric cancer
- •Previous Gastrectomy due to gastric cancer.
- •Patients with gastric cancer and previous systemic chemotherapy
- •Peritoneal recurrence due to gastric cancer.
- •Distance metastasis
- •SP >2 at recruitment or SP>1 at surgery
- •previous radiotherapy treatment
- •pregnant or breastfeeding women
结局指标
主要结局
disease free survival
时间窗: 36 months
patients who reached optimum cytoreduction (CC0)after Phase II and eligible to complete adjuvant treatment(Phase III).
次要结局
- progression free survival(36 months)
- overall survival in patients with CC0(36 month)
- overall survival in patients who did not reach optimum cytoreduction(36 months)
- morbidity and mortality(first 30 days after surgery procedure)
- Quality of life after phase I and Phase II(36 months)