A Multicenter Prospective Phase II Study of Modified FOLFIRINOX for 1st Line Treatment for Advanced Urachus Cancer

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of bladder/urachal remnant that is clinicallyconsistent with urachal cancer. Origin in the anterior wall or dome of the bladder Predominant invasion of muscularis ordeeper tissues No obvious origin from the overlying urothelium (relative normal-lookingurothelial mucosa) No primary adenocarcinoma elsewhere
• Patients with locally advanced, recurrent, or metastatic disease not amenable tosurgery, radiotherapy, or combined modality therapy with curative intent
• No prior systemic therapy for advanced urachal cancer. For recurrent disease, previous 5-FU, oxaliplatin, or irinotecan chemotherapy as neoadjuvant and/or adjuvant aim isallowed if it ended more than 6 months before enrollment.
• Measurable disease according to RECIST v1.1 criteria
• ECOG performance status 0 or 1
• Age 19 years or older
• Adequate cardiac function
• Adequate bone marrow, hepatic, and renal function Hematology
• Life expectancy more than 3 months
• Signed and dated informed consent of document indicating that the patient (or legallyacceptable representative) has been informed of all pertinent aspects of the trialprior to enrollment
• Contraceptive use by men and women should be consistent with local regulationsregarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

• Age > 65
• Previous radiotherapy to the only measurable lesion: but previous radiotherapy will bepermitted unless the lesion is the only measurable lesion
• Uncontrolled CNS metastasis (brain and/or leptomeningeal metastasis)
• Grade 2 or more peripheral neuropathy
• Diagnosis of any serious secondary malignancy within the last 2 years, except foradequately treated basal cell or squamous cell carcinoma of skin, or in situ carcinomaof cervix uteri or prostate cancer and curatively treated thyroid cancer of any stage.
• Pregnancy or breast feeding, or intention of becoming pregnant during study treatmentor within 6 months after final dose
• Other severe acute or chronic medical or psychiatric condition
• Chronic diarrhea
• Clinically significant cardiac disease (heart failure, coronary artery disease, and/orarrhythmia)
• Hypersensitivity to study medication
• treatment with a prohibited medication or anticipation of need for prohibitedmedication ( section 5.5 )