ISRCTN17575409进行中（未招募）Unknown
Pressurised IntraPeritoneal Aerosolised Chemotherapy (PIPAC) in the management of cancers of the colon, ovary and stomach: a randomised controlled phase II trial of efficacy in peritoneal metastases
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 216
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •All disease groups:
- •1. 16 years and older
- •2. Visible (measurable or non-measurable) peritoneal lesion(s) on computerised tomography (CT) imaging as per Response Evaluation
- •Criteria in Solid Tumours (RECIST) v1.1
- •3. Eastern Cooperative Oncology Group (ECOG) performance status 0–1
- •4. Adequate bone marrow, liver and kidney function (within 7 days prior to randomisation):
- •4.1. Neutrophil =1.5×10^9/L
- •4.2. White blood cells =3.0 x 10^9/L
- •4.3. Platelets =100×10^9/L
- •4.4. Haemoglobin =90 g/l
- •4.5. Serum bilirubin =3 x ULN
- •4.6. ALT/AST =2.5 x ULN (if both done, both must meet criteria)
- •4.7. Creatinine clearance =60 ml/min
- •5. Fit enough to receive full dose of systemic anti-cancer therapy (SACT) in cycle 1 as defined in the protocol.
- •6. Ability to provide informed consent obtained prior to any trial-specific screening procedures.
- •Colorectal group only:
- •1. PM from histologically proven primary adenocarcinoma of the colorectum.
- •Ovarian group only:
- •1. PM from histologically confirmed primary epithelial ovarian, tubal, or primary peritoneal platinum-resistant carcinoma (including clinical recurrence, refractory disease, or persistent disease within 6 months of last chemotherapy).
- •Stomach group only:
- •1. PM from histologically proven primary adenocarcinoma (any subtype) of stomach or Siewert type 3 gastro-oesophageal junction tumour (any Human Epidermal Growth Factor Receptor 2 [HER2] status or Combined Positive Score [CPS]).
排除标准
- •All disease groups:
- •1. Any prior malignancy not considered in complete remission for at least 2 years, excluding non-melanoma skin cancer
- •2. Pregnant or breastfeeding
- •3. Untreated central nervous system disease or symptomatic central nervous system metastasis, history, or evidence of thrombotic or haemorrhagic disorders not considered currently in complete remission
- •4. Bevacizumab/aflibercept should not be used in either arm (minimum 4 weeks from any prior bevacizumab/aflibercept)
- •5. Contraindication to any drug contained in the chemotherapy regimen
- •6. Medical, geographical, sociological, psychological, or legal conditions that would prevent the patient from completing the study or signing the informed consent
- •7. Unresolved bowel obstruction or parenteral nutrition or gastric tube
- •8. Contraindication to surgery
- •9. Participating in other oncological trials that may impact on endpoint
- •Added 26/03/2024: 10. Life expectancy <3 months
- •Colorectal group only:
- •1. Extra-peritoneal metastases except for:
- •1.1. retroperitoneal lymph nodes <2cm
- •1.2. lung metastases; with < 5 lung metastases none >1cm
- •2. Eligible for and chooses cytoreductive surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) upfront
- •3. Prior systemic therapy for colorectal cancer in the last 6 months
- •4. Dihydropyrimidine Dehydrogenase Deficiency (DPYD) variant detected
- •5. Microsatellite instability (MSI) high
- •Added 26/03/2024: 6. Previous cytoreductive surgery (CRS) or Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
- •Ovarian group only:
- •1. Extra-peritoneal metastases (with the exception of retroperitoneal lymph nodes)
- •2. Parenchymal liver or spleen metastases
- •3. Malignant pleural effusion
- •4. Non-epithelial pathology subtype
- •5. Peritoneal disease, amenable to surgical resection
- •Stomach group only:
- •1. Extra-peritoneal metastases (with the exception of retroperitoneal lymph nodes)
- •2. Prior systemic anti-cancer therapy, radiotherapy or surgery for stomach cancer
- •3. Gastric or duodenal stent in-situ
- •4. Gastro-oesophageal junction Sievert Type 1 or Type 2 tumour
- •5. Symptoms and/or radiology suggestive of impending and/or current bowel obstruction
- •6. Uncontrolled and persistent ascites
- •7. MSI high
- •8. DPYD variant detected
- •Added 26/03/2024: 6. Previous cytoreductive surgery (CRS) or Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
研究者
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