Table 2

Study procedures

Before first visitFirst visitSecond visitDLSFirst postoperative visitIntraperitoneal chemotherapy (CTx)Response evaluationIntraperitoneal CTx
9th–16th cycles*
Response evaluationLast study visit
First cycleSecond cycleThird cycleFourth cycleFifth cycleSixth cycleSeventh cycleEighth cycle
MTB†XX
Medical historyXX
Inclusion/exclusion criteriaX
Provide information about the studyXX
Written informed consentX
Vital signsXXXXXXXXXXX
Physical examination (including weight)‡XXX‡X‡X‡X‡X‡X‡X‡X‡X‡
Operability check (anaesthetist)X
Haematology and blood chemistryXX‡XXXXXXXXX
Viral serologyX
Pregnancy test‡X
Placement of peritoneal PAC§X
Visit medical oncologistXXXX
CT scan chest/abdomenX**XX‡‡
Intraperitoneal chemotherapyXXXXXXXXX
Performance statusXXXXXXXXXXXXX
Chemotherapy toxicity evaluation (CTCAE 5.0)XXXXXXXXXXX
Collection of blood and peritoneal fluid for PK analysisXX
Removal of peritoneal PACX††
  • *In case of no progression of disease (ie, CR, PR or SD) and if the patient is willing.

  • †Scans and reports of (referred) patients are first discussed in a multidisciplinary tumour board. When patients are considered candidates for HIPEC procedure, they are seen in the outpatient clinic.

  • ‡If applicable.

  • §In case complete cytoreduction is deemed impossible.

  • ¶If not performed by referring centre.

  • **Maximum of 4 weeks before start of study treatment.

  • ††Optional, according to patient preference and life expectancy.

  • ‡‡At cycle 16 if applicable.

  • CR, complete response; CTCAE, Common Terminology Criteria for Adverse Events; DLS, diagnostic laparoscopy; HIPEC, hyperthermic intraperitoneal chemotherapy; MTB, multidisciplinary tumour board; PAC, port-a-cath; PK, pharmacokinetic; PR, partial response; SD, stable disease.