Table 1.

WHO trial registration data set

Primary registry and trial identifying number	EudraCT number: 2021-003637-11 Netherlands Trial Register: NL9718
Date of registration in primary registry	September 2021
Protocol version	Protocol version 4.0; 22 November 2021
SPIRIT guidelines data set for clinical trials	See online supplemental file 1.
Secondary identifying numbers	Dutch competent authority (CCMO): NL78373.078.21 Local medical ethics committee (METC): MEC-2021-0697
Source(s) of monetary or material support	Erasmus MC Foundation, Rotterdam, The Netherlands
Primary sponsor	Erasmus University Medical Center, Rotterdam, The Netherlands
Secondary sponsors	Not applicable
Contact for public queries	MVD, study coordinator Department of Surgical Oncology Erasmus MC, Rotterdam, The Netherlands m.dietz@erasmusmc.nl, (+31)010–7042125
Contact for scientific queries	EVEM, principal investigator Department of Surgical Oncology Erasmus MC, Rotterdam, The Netherlands e.madsen@erasmusmc.nl, (+31)010–7041082
Public title	Treatment of abdominal mesothelioma with intra-abdominal chemotherapy: INTERACT MESO
Scientific title	Intraperitoneal paclitaxel for patients with primary malignant peritoneal mesothelioma—a phase I/II dose escalation and safety study: INTERACT MESO
Countries of recruitment	The Netherlands
Health conditions or problems studied	Malignant peritoneal mesothelioma
Interventions	Patients undergo a diagnostic laparoscopy (DLS) according to standard work-up for CRS-HIPEC. If the disease is considered not resectable, a peritoneal port-a-cath (PAC) will be placed. Through this PAC, intraperitoneal paclitaxel will be administered in weekly cycles.
Key inclusion and exclusion criteria	Key inclusion criteria: Confirmed diagnosis of malignant peritoneal mesothelioma, WHO-ECOG performance status 0–1, aged ≥18 years old and adequate organ function and bone marrow reserves Key exclusion criteria: Extra-abdominal disease/metastatic disease, serious concomitant disease or active infections, any medical or psychological impediment to probable compliance with the protocol and pregnant or lactating women
Study type	Open-label single-centre phase I/II study
Date of first enrolment	Planned February 2022
Target sample size	11–21 according to dose escalation
Recruitment status	Pending
Primary outcome	Maximum tolerable dose (MTD) of intraperitoneal paclitaxel monotherapy in patients with MPM
Key secondary outcome(s)	Safety and toxicity, feasibility and the pharmacokinetic profile of intraperitoneal paclitaxel monotherapy

CCMO, Central Committee on Research Involving Human Subjects; CRS, cytoreductive surgery; ECOG, Eastern Cooperative Oncology Group; HIPEC, hyperthermic intraperitoneal chemotherapy; METC, Medical Research Ethics Committee; MPM, malignant peritoneal mesothelioma; SPIRIT, Standard Protocol Items: Recommendations for Interventional Trials.