ISRCTN15977568进行中（未招募）2 期
Current scientific title as of 11/01/2019:Perioperative systemic therapy and cytoreductive surgery with HIPEC verus upfront cytoreductive surgery with HIPEC alone for isolated resectable colorectal peritoneal metastases: a multicentre, open-label, parallel-group, phase II-III, randomised superiority studyPrevious scientific title:Perioperative systemic therapy and surgery versus surgery alone for resectable colorectal peritoneal metastases: a multicentre, phase II-III, randomised controlled study
Catharina Hospital (Netherlands)0 个研究点目标入组 358 人开始时间: 2016年5月11日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 358
研究概览
简要总结
2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31023318 protocol (added 29/04/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 11/01/2019:
- •1. A World Health Organisation (WHO) performance status of =1
- •2. Histological or cytological proof of peritoneal metastases of a non-appendiceal colorectal adenocarcinoma with =50% of the tumour cells being signet ring cells
- •3. Resectable disease determined by abdominal computed tomography (CT) and a diagnostic laparoscopy/laparotomy
- •4. No evidence of systemic colorectal metastases within three months prior to enrolment
- •5. No systemic therapy for colorectal cancer within six months prior to enrolment
- •6. No contraindications for CRS-HIPEC
- •7. No previous CRS-HIPEC
- •8. No concurrent malignancies that interfere with the planned study treatment or the prognosis of resected colorectal peritoneal metastases.
- •Importantly, enrolment is allowed for patients with radiologically non-measurable disease. The diagnostic laparoscopy/laparotomy may be performed in a referring centre, provided that the peritoneal cancer index (PCI) is appropriately scored and documented before enrolment.
- •Inclusion criteria as of 04/05/2017:
- •1. PCI score =20 and CC-0 or CC-1 achievable, determined by adequate preoperative work-up
- •2. Histological confirmation of non-appendiceal colorectal cancer with non-signet histology in peritoneal deposits or ascites
- •3. 18 years or older
- •4. WHO performance score 0-1
- •5. Adequate clinical condition to undergo cytoreductive surgery with HIPEC and/or neoadjuvant combination chemotherapy with bevacizumab within 4 weeks after randomisation
- •6. Adequate organ functions: normal bone marrow function (Hb =6.0 mmol/L, absolute neutrophil count =1.5 x 109/L, platelet count =100 x 109/L), renal function (serum creatinine =1.5 x ULN and creatinine clearance [Cockroft formula] =30 ml/min), determined <3 months prior to randomisation;
- •7. No known bleeding diathesis or coagulopathy
- •8. Written informed consent
- •9. Able and willing to adhere to follow-up
- •Previous inclusion criteria:
- •1. Peritoneal Cancer Index (PCI) score =20, determined by diagnostic staging laparoscopy
- •2. Achievability of complete cytoreduction, determined by diagnostic staging laparoscopy
- •3. Pathological confirmation of non-signet adenocarcinoma in peritoneal deposits or ascites
- •4. 18 years or older
- •5. WHO performance score 0-1
- •6. Adequate clinical condition to undergo CRS + HIPEC and neoadjuvant systemic therapy within 4 and 3 weeks after staging laparoscopy, respectively
- •7. Neutrophil count of at least 3.000/mm3, platelet count of at least 100,000/mm3 (<3 months before inclusion)
- •8. No bleeding diathesis or coagulopathy
- •9. Normal creatinine or creatinine clearance, determined by the MDRD-formula, of at least 50 ml/min (<3 months before inclusion)
- •10. Written informed consent
- •11. Expected adequacy of follow-up
排除标准
- •Current exclusion criteria as of 11/01/2019:
- •1. Inadequate bone marrow, renal, or liver functions (e.g. haemoglobin <6.0 mmol/L, neutrophils <1.5 x 109/L, platelets <100 x 109/L, serum creatinine >1.5 x ULN, creatinine clearance <30 ml/min, bilirubin >2 x ULN, serum liver transaminases >5 x ULN);
- •2. Previous intolerance of fluoropyrimidines or both oxaliplatin and irinotecan;
- •3. Dehydropyrimidine dehydrogenase deficiency;
- •4. Serious active infections;
- •5. Severe diarrhoea;
- •6. Stomatitis or ulceration in the mouth or gastrointestinal tract;
- •7. Recent major cardiovascular events;
- •8. Unstable or uncompensated respiratory or cardiac disease;
- •9. Bleeding diathesis or coagulopathy;
- •10. Pregnancy or lactation.
- •Exclusion criteria as of 04/05/2017:
- •1. Signet ring cell histology (>50% of the cells have signet ring cell histology) of the primary tumour
- •2. Systemic metastases (i.e. liver, lung)
- •3. Known pregnancy or lactation, wish for pregnancy, and not willing to use contraceptives
- •4. Known unstable or uncompensated respiratory or cardiac disease
- •5. Serious active infections
- •6. Adjuvant chemotherapy after primary resection of colorectal cancer within 6 months prior to randomisation;
- •7. Any condition not allowing the safe administration of the planned systemic treatment (bevacizumab, 5-fluorouracil, leucovorin, capecitabine, oxaliplatin, irinotecan)
- •8. Stomatitis, ulceration in the mouth or gastrointestinal tract
- •9. Severe diarrhoea
- •10. Known pernicious anaemia or other anaemias due to vitamin B12 deficiency
- •11. Known previous peripheral sensory neuropathy with functional impairment after previous use of oxaliplatin
- •12. Impaired liver function (serum bilirubin =2 x ULN, serum transaminases =5 x ULN), assessment only if indicated
- •Previous exclusion criteria from 02/09/2016 to 04/05/2017:
- •1. Signet ring cell histology (>50% of the cells have signet ring cell histology) of the primary tumour
- •2. Systemic metastases (i.e. liver, lung)
- •3. Known pregnancy or lactation
- •4. Known unstable or uncompensated respiratory or cardiac disease
- •5. Serious active infections
- •6. Adjuvant chemotherapy after primary resection of colorectal cancer used within 6 months prior to randomisation
- •7. Any condition not allowing the safe administration of the planned systemic treatment (bevacizumab, 5-fluorouracil, leucovorin, capecitabine, oxaliplatin, irinotecan)
- •8. Stomatitis, ulceration in the mouth or gastrointestinal tract
- •9. Severe diarrhoea
- •10. Known pernicious anaemia or other anaemias due to vitamin B12 deficiency
- •11. Known previous peripheral sensory neuropathy with functional impairment after previous use of oxaliplatin.
- •12. Impaired liver function (serum bilirubin =2 x ULN, serum transaminases =5 x ULN), assessment only if indicated
- •13. Known dihydropyrimidine dehydrogenase deficiency, determined by dihydropyrimidine dehydrogenase genotyping
- •Original exclusion criteria:
- •1. Signet ring cell histology (>50% of the cells have signet ring cell histology) of the primary tumour
- •2. Pregnant or lactating women
- •3. Unstable or uncompensated respiratory or cardiac disease
- •4. Serious active infections
- •5. Other concurrent chemotherapy used within 6 months prior to inclusion
- •6. Any condition not allowing the safe administration of the planned systemic treatment (bevacizumab, fluorouracil, folinic acid, capecitabine or oxaliplatin/irinotecan)
- •7. Stomatitis, ulceration in the mouth or gastrointestinal tract
- •8. Severe diarrhoea
- •9. Severe hepatic and/or renal dysfunction
- •10. Plasma
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