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Adjuvant CAPECITABINE in High Risk PSEUDOMYXOMA PERITONEI Patients

NCT05321329 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2022-04-11

No results posted yet for this study

Summary

This is a phase II, mono institutional, non comparative study, evaluating adjuvant capecitabine in patients affected by KRAS mutated Pseudomyxoma peritonei treated with cytoreductive surgery and HIPEC.

Patient will be treated with 8 cycles of the study regimen that include:

Capecitabine 1250 mg/m2 PO BID day 1-14 q21 days

Conditions

  • Pseudomyxoma Peritonei

Interventions

DRUG

Capecitabine

Capecitabine is a deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.Capecitabine is a Nucleoside Metabolic Inhibitor. The mechanism of action of capecitabine is as a Nucleic Acid Synthesis Inhibitor.

Sponsors & Collaborators

  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    lead OTHER

Principal Investigators

  • Maria Di Bartolomeo, MD · IRCCS Istituto Nazionale Tumori MIlano

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
76 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-03
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05321329 on ClinicalTrials.gov