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Metronomic neoadjuvant capecitabine and cyclophosphamide in huge (PCI>28) Pseudomyxoma peritonei (PMP) patients candidates to cytoreductive surgery (CRS) and hypertermic intraperitoneal chemotherapy (HIPEC).

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514329-42-00
Acronym
REVERSE
Enrollment
31
Registered
2024-09-23
Start date
2024-11-22
Completion date
Unknown
Last updated
2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pseudomyxoma peritonei patients with high tumor burden.

Brief summary

We will use Completeness of Cytoreduction to evaluate the radicality of CRS: patients with a residual disease <2.5 mm will be considered completely cytoreduced, otherwise incompletely cytoreduced,

Detailed description

Objective tumor response rate will be defined by two independent radiologists by means of CT (computed tomography) scans performed at baseline, and after 16 weeks., Conversion rate will be calculated dividing the number of resectable cases after the neoadjuvant chemotherapy by the number of resectable cases before neoadjuvant chemotherapy. Resectability will be evaluated with CT scans using Bouquot et al. methodology., Downsizing of the tumor will be measured at the time of staging laparoscopy and CRS using Peritoneal Cancer Index (PCI)., Safety and tolerability objective will be measured by the incidence of adverse events (AEs), serious adverse events (SAEs), deaths, and laboratory abnormalities., Major complications associated with CRS and HIPEC will be measured using NCI-CTCAE v5., Quality of life will be assessed before/after neoadjuvant metronomic chemotherapy, and 30 days after the surgery with EORTC-QLQ-30 and EQ-5D-5L., Progression-free Survival (PFS) is the time between the date of chemotherapy commencement and the date of Disease-Progression or Death, whichever occurs first., Overall Survival (OS) is the time between the date of chemotherapy commencement and date of Death or last follow up., Conduction of biological studies.

Interventions

Sponsors

Fondazione IRCCS Istituto Nazionale Dei Tumori
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
We will use Completeness of Cytoreduction to evaluate the radicality of CRS: patients with a residual disease <2.5 mm will be considered completely cytoreduced, otherwise incompletely cytoreduced,

Secondary

MeasureTime frame
Objective tumor response rate will be defined by two independent radiologists by means of CT (computed tomography) scans performed at baseline, and after 16 weeks., Conversion rate will be calculated dividing the number of resectable cases after the neoadjuvant chemotherapy by the number of resectable cases before neoadjuvant chemotherapy. Resectability will be evaluated with CT scans using Bouquot et al. methodology., Downsizing of the tumor will be measured at the time of staging laparoscopy and CRS using Peritoneal Cancer Index (PCI)., Safety and tolerability objective will be measured by the incidence of adverse events (AEs), serious adverse events (SAEs), deaths, and laboratory abnormalities., Major complications associated with CRS and HIPEC will be measured using NCI-CTCAE v5., Quality of life will be assessed before/after neoadjuvant metronomic chemotherapy, and 30 days after the surgery with EORTC-QLQ-30 and EQ-5D-5L., Progression-free Survival (PFS) is the time between the da

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026