Bevacizumab for Colorectal peritoneal metastases

Inclusion criteria

• {"criterion_text":"- Histologically confirmed CRC (colorectal carcinoma)"}
• {"criterion_text":"- Pathologically or radiologically & clinically confirmed, non-appendiceal, adenocarcinoma with PM (peritoneal metastases)"}
• {"criterion_text":"- Synchronous or metachronous PM"}
• {"criterion_text":"- Macroscopic PM still present at time of inclusion/at diagnostic laparoscopy"}
• {"criterion_text":"- Surgical PCI (peritoneal cancer index) score 1 to, or equal to 20 (macroscopic disease)"}
• {"criterion_text":"- No systemic metastases, at enrolment"}
• {"criterion_text":"- WHO-performance score of 0 to 1 with a life expectancy greater than or equal to three months"}
• {"criterion_text":"- Aged above 18 years old"}
• {"criterion_text":"- Written informed consent"}

Exclusion criteria

• {"criterion_text":"- Prior cytoreductive surgery and/or HIPEC"}
• {"criterion_text":"- Inadequate organ functions (defined as a haemoglobin <5mmol/l, an absolute neutrophil count <1.5 x 109/l, platelet count <100 x 109/l, serum creatinine >1.5 x ULN, creatinine clearance <30ml/min, bilirubin >2x ULN and liver transaminases >2.5x ULN)"}
• {"criterion_text":"- Major cardiovascular events"}
• {"criterion_text":"- Severe diarrhoea"}
• {"criterion_text":"- Severe stomatitis/ulceration in the mouth or GI-tract"}
• {"criterion_text":"- Unstable or uncompensated respiratory and/or cardiac disease"}
• {"criterion_text":"- Bleeding diathesis or coagulopathy"}
• {"criterion_text":"- Pregnancy or lactation"}
• {"criterion_text":"- Prior systemic therapy for CRC within the six months before enrolment in this study"}
• {"criterion_text":"- Contra-indications for CRS-HIPEC; contrast administration (allergy)"}
• {"criterion_text":"- Signet cell carcinoma"}
• {"criterion_text":"- Multi drug resistant (MDR) tumors"}
• {"criterion_text":"- Microsatellite instable (MSI) tumour"}
• {"criterion_text":"- Homozygous UGT1A1*28 genotype"}
• {"criterion_text":"- Homozygous dihydropyrimidine dehydrogenase (DPD) deficiency"}
• {"criterion_text":"- Any contra-indication for the (planned) chemotherapy (e.g. active infection, serious concomitant disease, severe allergy, …), as determined by the medical oncologist"}

Primary endpoints

• {"endpoint_text":"- The number of patients that is able to undergo all trial treatments (minimally 4 cycles of IP and systemic chemotherapy, followed by CRS-HIPEC)","definition_or_measurement_approach":"Measured as the number of patients able to undergo all trial treatments (minimally 4 cycles of intraperitoneal and systemic chemotherapy, followed by CRS-HIPEC)."}

Secondary endpoints

• {"endpoint_text":"- Measured toxicity in patients during trial treatments (measured by the amount of AE/SAE and SUSAR)","definition_or_measurement_approach":"Measured by the number and severity of AEs, SAEs and SUSARs reported during trial treatments."}
• {"endpoint_text":"- Pathological response after trial treatment (assessed by the MANDARD scoring system and the Tumor Regression Grading System)","definition_or_measurement_approach":"Assessed using the MANDARD scoring system and the Tumor Regression Grading System on pathological specimens."}
• {"endpoint_text":"- Radiologic response measured by RECIST and PERCIST (ceCT vs. PET/CT)","definition_or_measurement_approach":"Radiologic response assessed by RECIST (CT) and PERCIST (PET/CT) criteria."}
• {"endpoint_text":"- Comparison of PCI-scores of the diagnostic laparoscopy, CRS-HIPEC, PET-CT and CT","definition_or_measurement_approach":"Comparison of peritoneal cancer index (PCI) scores obtained from diagnostic laparoscopy, CRS-HIPEC, PET-CT and CT."}
• {"endpoint_text":"- Quality of life assessment via EQ-5D-5L, QLQ-C30, QLQ-CR29, iMTA productivity cost questionnaire (PCQ), and iMTA medical consumption questionnaire (MCQ) at selected points during the trial","definition_or_measurement_approach":"Quality of life measured using EQ-5D-5L, QLQ-C30, QLQ-CR29, iMTA PCQ and iMTA MCQ at predefined time points."}
• {"endpoint_text":"- Disease free survival, after CRS-HIPEC, with a follow-up of 6 months","definition_or_measurement_approach":"Disease-free survival measured after CRS-HIPEC with a follow-up period of 6 months."}

Netherlands

Earliest CTIS Part Ii Submission Date

17-09-2024

Latest Decision Or Authorization Date

10-10-2024

Processing Time Days

23

Number Of Sites

4

Number Of Participants

40

Primary sponsor

Full Name

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands