Adjuvant CAPECITABINE in High Risk PSEUDOMYXOMA PERITONEI Patients (NCT05321329) | Clinical Trial Compass
UnknownPhase 2
Adjuvant CAPECITABINE in High Risk PSEUDOMYXOMA PERITONEI Patients
Italy28 participantsStarted 2018-12-03
Plain-language 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
Who can participate
Age range18 Years ā 76 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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 ā¦
What they're measuring
1
PFS
Timeframe: Progression free survival is time between treatment start date and first date of recurrence or death, whichever occurs first.
Trial details
NCT IDNCT05321329
SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano