PIPAC for peritoneal metastases of large bowel cancer

Phase 1

• Conditions: Isolated unresectable colorectal peritoneal metastases; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-000927-29-NL
• Lead Sponsor: Catharina Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-12
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 17
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

See inclusion criteria

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified