Chemo-immunotherapy before and after surgery for peritoneal metastases of large bowel cancer

Phase 1

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

• Registration Number: EUCTR2016-001865-99-NL
• Lead Sponsor: Catharina Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-14
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 358

Inclusion Criteria

Eligible patients are adults who have:
?a World Health Organisation (WHO) performance status of =1;
?histological or cytological proof of peritioneal metastases of a non-appendiceal colorectal adenocarcinoma with =50% of the tumour cells being signet ring cells;
?resectable disease determined by abdominal computed tomography (CT) and a diagnostic laparoscopy/laparotomy;
?no evidence of systemic colorectal metastases within three months prior to enrolment;
?no systemic therapy for colorectal cancer within six months prior to enrolment;
?no contraindications for cytorductive surgery with HIPEC;
?no previous cytoreductive surgery with HIPEC;
?no concurrent malignancies that interfere with the planned study treatment or the prognosis of resected colorectal peritoneal metastases.
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 179
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 179

Exclusion Criteria

Patients are excluded in case of any comorbidity or condition that prevents safe administration of the planned perioperative systemic therapy, determined by the treating medical oncologist, e.g.:
?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);
?Previous intolerance of fluoropyrimidines or both oxaliplatin and irinotecan;
?Dehydropyrimidine dehydrogenase deficiency;
?Serious active infections;
?Severe diarrhoea;
?Stomatitis or ulceration in the mouth or gastrointestinal tract;
?Recent major cardiovascular events;
?Unstable or uncompensated respiratory or cardiac disease;
?Bleeding diathesis or coagulopathy;
?Pregnancy or lactation.

Study & Design

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