Table 2.
Before first visit | First visit | Second visit | DLS | First postoperative visit | Intraperitoneal chemotherapy (CTx) | Response evaluation | Intraperitoneal CTx 9th–16th cycles* |
Response evaluation | Last study visit | ||||||||
First cycle | Second cycle | Third cycle | Fourth cycle | Fifth cycle | Sixth cycle | Seventh cycle | Eighth cycle | ||||||||||
MTB† | X | X | |||||||||||||||
Medical history | X | X | |||||||||||||||
Inclusion/exclusion criteria | X | ||||||||||||||||
Provide information about the study | X | X | |||||||||||||||
Written informed consent | X | ||||||||||||||||
Vital signs | X | X | X | X | X | X | X | X | X | X | X | ||||||
Physical examination (including weight)‡ | X | X | X‡ | X‡ | X‡ | X‡ | X‡ | X‡ | X‡ | X‡ | X‡ | ||||||
Operability check (anaesthetist) | X | ||||||||||||||||
Haematology and blood chemistry | X | X‡ | X | X | X | X | X | X | X | X | X | ||||||
Viral serology | X | ||||||||||||||||
Pregnancy test‡ | X | ||||||||||||||||
Placement of peritoneal PAC§ | X | ||||||||||||||||
Visit medical oncologist | X | X | X | X | |||||||||||||
CT scan chest/abdomen | X¶ | X** | X | X‡‡ | |||||||||||||
Intraperitoneal chemotherapy | X | X | X | X | X | X | X | X | X | ||||||||
Performance status | X | X | X | X | X | X | X | X | X | X | X | X | X | ||||
Chemotherapy toxicity evaluation (CTCAE 5.0) | X | X | X | X | X | X | X | X | X | X | X | ||||||
Collection of blood and peritoneal fluid for PK analysis | X | X | |||||||||||||||
Removal of peritoneal PAC | X†† |
*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.