Table 1

WHO trial registration data set

Primary registry and trial identifying numberEudraCT number: 2021-003637-11
Netherlands Trial Register: NL9718
Date of registration in primary registrySeptember 2021
Protocol versionProtocol version 4.0; 22 November 2021
SPIRIT guidelines data set for clinical trialsSee online supplemental file 1.
Secondary identifying numbersDutch competent authority (CCMO): NL78373.078.21
Local medical ethics committee (METC): MEC-2021-0697
Source(s) of monetary or material supportErasmus MC Foundation, Rotterdam, The Netherlands
Primary sponsorErasmus University Medical Center, Rotterdam, The Netherlands
Secondary sponsorsNot applicable
Contact for public queriesMVD, study coordinator
Department of Surgical Oncology
Erasmus MC, Rotterdam, The Netherlands
m.dietz@erasmusmc.nl, (+31)010–7042125
Contact for scientific queriesEVEM, principal investigator
Department of Surgical Oncology
Erasmus MC, Rotterdam, The Netherlands
e.madsen@erasmusmc.nl, (+31)010–7041082
Public titleTreatment of abdominal mesothelioma with intra-abdominal chemotherapy: INTERACT MESO
Scientific titleIntraperitoneal paclitaxel for patients with primary malignant peritoneal mesothelioma—a phase I/II dose escalation and safety study: INTERACT MESO
Countries of recruitmentThe Netherlands
Health conditions or problems studiedMalignant peritoneal mesothelioma
InterventionsPatients 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 criteriaKey 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 typeOpen-label single-centre phase I/II study
Date of first enrolmentPlanned February 2022
Target sample size11–21 according to dose escalation
Recruitment statusPending
Primary outcomeMaximum 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.