Adjuvant CAPECITABINE in High Risk PSEUDOMYXOMA PERITONEI Patients Treated With CYTOREDUCTIVE SURGERY (CRS) and HYPERTERMIC INTRAPERITONEAL CHEMOTHERAPY (HIPEC)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
This is a phase II, mono institutional, non comparative study, evaluating adjuvant capecitabine in patients affected by KRAS mutated Pseudomyxoma peritonei treated with cytoreductive surgery and HIPEC.
Patient will be treated with 8 cycles of the study regimen that include:
Capecitabine 1250 mg/m2 PO BID day 1-14 q21 days
详细描述
A previous phase II study evaluated the combination of systemic concurrent mitomycin C and capecitabine in advanced unresectable PMP.
Fifteen out of 39 patients benefited from chemotherapy in the form of either reductions in mucinous deposition or stabilisation of progressive pretreatment disease determined on CT scan. Notably, two patients, originally considered unresectable, underwent potentially curative cytoreductive surgery. One-year and two-year tumour-related survival rates for the 40 patients were 84% and 61%, respectively.
FOLFOX-4 chemotherapy was evaluated on 20 patients with unresectable or recurrent PMP, obtaining a 20% response rate and a 65% disease control rate, 2 patients originally considered unresectable underwent complete cytoreduction. Median PFS and median OS were 8 months and 26.2 months respectively.
In a retrospective review of MCP (mucinous cancer peritonei) patients who had undergone CRS/HIPEC with or without perioperative systemic chemotherapy (any regimen), postoperative chemotherapy was associated with longer PFS (13.6 months) compared to pre-operative treatment (6.8 months, P < 0.01) and CRS/HIPEC alone (7.0 months, P = 0.03).
The OS of patients treated with systemic chemotherapy after previous CRS and HIPEC appeared to be associated with the length of PFS after primary treatment (p=0.04).
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 76 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients submitted to a complete cytoreductive surgery and subsequent HIPEC for PMP
- •Histological diagnosis of pseudomyxoma peritonei (PMP)
- •Assessment of KRAS mutation positivity on surgical sample
- •Age >= 18 years and <76 years
- •Performance Status (ECOG <2)
- •Adequate organ function including the following:
- •Adequate bone marrow reserve: WBC count >3.0x109/L, absolute neutrophyl count >1.5x109/L, platelet count >100x109/L, and hemoglobin >10 g/dL
- •Hepatic: bilirubin < 1.5 times the ULN, alkaline phosphatase, aspartate transaminase, and alanine transaminase < 2.5 xULN
- •Renal: Creatinine clearance >50 mL/min or serum creatinine 1.5 x UNL
- •Patients compliance and geographic proximity that allows for adequate follow-up
- •Patients must sign an informed consent document (ICD)
- •Male and female patients with reproductive potential must use an approved contraceptive method.
排除标准
- •Previous systemic chemotherapy and/or biological therapy
- •Administration of other experimental drugs during the study
- •Pregnancy and breast-feeding
- •Serious or uncontrolled medical pathologies or active infections that would jeopardize the possibility of receiving the investigated treatment
- •Disorders that could influence the absorption of capecitabine (e.g. malabsorption), intestinal occlusion, Crohn's disease or ulcerative colitis
- •Psychiatric disorders, neurologic disease or other conditions that would make it impossible to comply with the protocol procedures.
- •Positive anamnesis with regard to other neoplastic diseases except for the ones that have been cured for more than 5 years
研究组 & 干预措施
Single Arm
Capecitabine will be taken orally at dose of 1250 mg/m2 PO BID on days 1→14 every 3 weeks Cycles are to be repeated every 21 days for a total of 8 cycles
干预措施: Capecitabine (Drug)
结局指标
主要结局
PFS
时间窗: Progression free survival is time between treatment start date and first date of recurrence or death, whichever occurs first.
To evaluate the efficacy of postoperative capecitabine in terms of progression free survival (PFS) after CRS and HIPEC in patients with KRAS mutated PMP with extensive peritoneal disease
次要结局
- OS(Overall survival (OS) is time between the date of chemotherapy start and the date of death. For subjects without documentation of death, OS will be censored on the last date the subject was known to be alive)
- DSS(Disease Specific Survival (DSS) is time between the date of chemotherapy start and the date of death caused by cancer. Deaths from other causes are not "events".)