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OncoMatch/Clinical Trials/NCT06800391

Metronomic Neoadjuvant Capecitabine and Cyclophosphamide in HUGE Pseudomyxoma Peritonei Patients

Is NCT06800391 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Capecitabine 1250 mg/m2 /day - Cyclophosphamide 50Mg/day for pseudomyxoma peritonei.

Phase 2RecruitingFondazione IRCCS Istituto Nazionale dei Tumori, MilanoNCT06800391Data as of Jun 2026Location: Italy

Treatment: Capecitabine 1250 mg/m2 /day - Cyclophosphamide 50Mg/dayThe goal of this clinical trial is to evaluate the safety and efficacy of neoadjuvant capecitabine and cyclophosphamide treatment in patients affected by huge Pseudomyxoma peritonei (PMP) (peritoneal cancer index \>28). Treatment consists of metronomic (low-dose medication for a prolonged time) of capecitabine plus cyclophosphamide for 6 months followed by standard of care cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). The main question the trial aims to answer is which is the proportion of patients with complete cytoreduction at CRS/HIPEC after neoadjuvant metronomic approach with oral capecitabine and cyclophosphamide in patients affected by huge PMP.

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Extracted eligibility criteria

Treatments studied

Chemotherapy

Capecitabine 1250 mg/m2 /day - Cyclophosphamide 50Mg/day

Biomarker criteria

Excluded: DPYD deficiency

DPD deficiency

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 76

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic chemotherapy

Previous systemic chemotherapy

Cannot have received: biological therapy

Previous...biological therapy

Lab requirements

Blood counts

wbc count >3.0x109/l, absolute neutrophyl count >1.5x109/l, platelet count >100x109/l, and hemoglobin >10 g/dl

Kidney function

creatinine clearance >50 ml/min or serum creatinine <1.5 x unl

Liver function

bilirubin < 1.5 times the uln, alkaline phosphatase, aspartate transaminase, and alanine transaminase < 2.5 x uln

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT06800391 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Are patients with DPYD alterations eligible?

No. DPYD deficiency is an exclusion criterion.

Is there an age limit?

Yes. Patients must be 76 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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