Status:
UNKNOWN
Adjuvant CAPECITABINE in High Risk PSEUDOMYXOMA PERITONEI Patients
Lead Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Conditions:
Pseudomyxoma Peritonei
Eligibility:
All Genders
18-76 years
Phase:
PHASE2
Brief 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...
Detailed Description
A previous phase II study evaluated the combination of systemic concurrent mitomycin C and capecitabine in advanced unresectable PMP. Fifteen out of 39 patients benefited from chemotherapy in the for...
Eligibility Criteria
Inclusion
- Patients submitted to a complete cytoreductive surgery and subsequent HIPEC for PMP
- Histological diagnosis of pseudomyxoma peritonei (PMP)
- Assessment of KRAS mutation positivity on surgical sample
- Age \>= 18 years and \<76 years
- Performance Status (ECOG \<2)
- Adequate organ function including the following:
- Adequate bone marrow reserve: WBC count \>3.0x109/L, absolute neutrophyl count \>1.5x109/L, platelet count \>100x109/L, and hemoglobin \>10 g/dL
- Hepatic: bilirubin \< 1.5 times the ULN, alkaline phosphatase, aspartate transaminase, and alanine transaminase \< 2.5 xULN
- Renal: Creatinine clearance \>50 mL/min or serum creatinine 1.5 x UNL
- Patients compliance and geographic proximity that allows for adequate follow-up
- Patients must sign an informed consent document (ICD)
- Male and female patients with reproductive potential must use an approved contraceptive method.
Exclusion
- Previous systemic chemotherapy and/or biological therapy
- Administration of other experimental drugs during the study
- Pregnancy and breast-feeding
- Serious or uncontrolled medical pathologies or active infections that would jeopardize the possibility of receiving the investigated treatment
- Disorders that could influence the absorption of capecitabine (e.g. malabsorption), intestinal occlusion, Crohn's disease or ulcerative colitis
- Psychiatric disorders, neurologic disease or other conditions that would make it impossible to comply with the protocol procedures.
- Positive anamnesis with regard to other neoplastic diseases except for the ones that have been cured for more than 5 years
Key Trial Info
Start Date :
December 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT05321329
Start Date
December 3 2018
End Date
December 1 2023
Last Update
April 11 2022
Active Locations (1)
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1
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
Milan, MI, Italy, 20133