NCT05449366

Intraperitoneal Paclitaxel for Patients With Primary Malignant Peritoneal Mesothelioma - a Phase I/II Dose Escalation and Safety Study

Extracted Fields (from Registry)
Protocol IDNCT05449366
Registration Date2022-07-08
Statuscompleted
SponsorErasmus Medical Center
CountryNetherlands
Industrynot industry
Blindingunblinded
Center Typesingel-center RCT
Scopenational RCT
First Patient In2022-02-01
Last Patient Out2025-08-01
Publicationn
Gender %ALL
Mean Age18 Years -
LLM Classifications (Side-by-Side)
Field CLAUDE
claude-sonnet-4-20250514
Thinking: claude-opus-4-20250514
5593ms / 11344 tok 		OPENAI
gpt-4o
Thinking: o3
3540ms / 9775 tok 		GLM
glm-5.1
7875ms / 9956 tok 		Review
rct_type N/A N/A N/A OK
cancer_status Cancer Cancer Cancer OK
non_cancer_spec N/A N/A N/A OK
setting_patient outpatient inpatient → outpatient
shaky reasoning
✓ Unanimous Initial: inpatient Requery: outpatient — Patients receive weekly intraperitoneal chemotherapy cycles through a port-a-cath system, which is typically delivered in an outpatient clinic setting where patients come for treatment and return home the same day.
 outpatient outpatient → outpatient
shaky reasoning
✓ Unanimous Initial: outpatient Requery: outpatient — The intervention of intraperitoneal chemotherapy is administered through an IP port-a-cath system, which is typically done on an outpatient basis, as patients are ambulatory and return to the medical center for follow-up.
 outpatient OK
setting_place hospital hospital hospital OK
feasibility N/A feasibility RCT → feasibility RCT → N/A
shaky reasoning
✓ Unanimous Initial: feasibility RCT Requery: feasibility RCT — This is a phase I/II dose escalation study with only 7 patients enrolled that explicitly aims to assess feasibility as a secondary outcome and focuses on determining maximum tolerable dose rather than clinical effectiveness. Thinking: N/A — This is a single-arm dose escalation study, not a randomized controlled trial
 N/A fully powered RCT → feasibility RCT → N/A
shaky reasoning
✓ Unanimous Initial: fully powered RCT Requery: feasibility RCT — The primary aim includes determining feasibility, and the enrollment is low at 7 participants, suggesting a pilot phase. Thinking: N/A — Single-arm phase I/II dose-escalation study, not a randomized controlled trial.
 N/A OK
intervention_pharmacologic yes yes yes OK
intervention_chemo_immuno_radio yes yes yes OK
intervention_complementary no no no OK
intervention_device yes yes → yes → yes
shaky reasoning
✓ Unanimous Initial: yes Requery: yes — The study involves placement of a peritoneal port-a-cath (PAC) system during diagnostic laparoscopy, which is a physical medical device used to deliver intraperitoneal chemotherapy. Thinking: yes — The study uses a peritoneal port-a-cath (PAC), which is a physical implanted device for administering intraperitoneal chemotherapy.
 yes no → yes → yes
shaky reasoning
✓ Unanimous Initial: no Requery: yes — The trial involves the use of an intraperitoneal port-a-cath (PAC) system for administering chemotherapy, which is a physical device. Thinking: yes — Chemotherapy is administered through an implanted peritoneal port-a-cath, a physical medical device.
 no –
intervention_psychological no no no OK
intervention_complex no no no OK
intervention_acp no no no OK
intervention_music no no no OK
intervention_screening no no no OK
intervention_palliative no no no OK
intervention_education no no no OK
intervention_digital no no no OK
intervention_other no no no OK
outcome_symptom no no no OK
outcome_qol no no no OK
outcome_dignity no no no OK
outcome_cost no no no OK
outcome_other yes yes yes OK
pharmacologic_sub chemotherapy chemotherapy chemotherapy OK
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