Repetitive electrostatic pressurised intraperitoneal aerosol chemotherapy with oxaliplatin as a palliative monotherapy for isolated unresectable colorectal peritoneal metastases: protocol of a multicentre, open-label, single-arm, phase II study (CRC-PIPAC) - CRC-PIPAC

Catharina-ziekenhuis0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

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•Eligible patients are adults who have:;* a World Health Organisation (WHO) performance status of *1 and life expectancy >3 months;
•* histological or cytological proof of PM of a colorectal or appendiceal carcinoma;
•* unresectable disease determined by abdominal computed tomography (CT) and a diagnos-tic laparoscopy or laparotomy;
•* adequate organ functions (haemoglobin *5.0 mmol/L, neutrophils *1.5 x 109/L, platelets *100 x 109/L, serum creatinine <1.5 x ULN, creatinine clearance *30 ml/min, and liver trans-aminsases <5 x ULN);
•* no symptoms of gastrointestinal obstruction;
•* no radiological evidence of systemic metastases;
•* no contraindications for oxaliplatin or 5-fluorouracil/leucovorin;
•* no contraindications for a laparoscopy;
•* no previous PIPAC-procedures;
•* written informed consent.;Importantly, enrolment is allowed for patients with an unresected primary tumour (if asymptomatic) and for patients in various lines of palliative treatment, including patients who refuse, have not had, or do not qualify for first-line palliative systemic therapy. All potentially eligible patients are discussed in a multidisplinary team. Enrolled patients need to be informed about the potential consequences of postponing or discontinuing standard palliative treatment by a medical oncologist prior to enrolment.

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