A Multicenter Prospective Phase II Study of modified FOLFIRINOX for 1st line treatment for advanced urachus cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0005551

Enrollment

Registered

2020-10-29

Start date

2020-12-01

Completion date

Unknown

Last updated

2020-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : oxaliplatin 85 mg/m2 IV q 2weeks up to 12cycle irinotecan 150 mg/m2 IV q 2weeks up to 12cycle 5-FU continuous infusion 2400 mg/m2 continuous infusion over 46 hours IV Q 2weeks up to 12

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed adenocarcinoma of bladder/urachal remnant that is clinically consistent with urachal cancer. ? Origin in the anterior wall or dome of the bladder ? Predominant invasion of muscularis or deeper tissues ? No obvious origin from the overlying urothelium (relative normal-looking urothelial mucosa) ? No primary adenocarcinoma elsewhere 2) Patients with locally advanced, recurrent, or metastatic disease not amenable to surgery, radiotherapy, or combined modality therapy with curative intent 3) No prior systemic therapy for advanced urachal cancer. For recurrent disease, previous 5-FU, oxaliplatin, or irinotecan chemotherapy as neoadjuvant and/or adjuvant aim is allowed if it ended more than 6 months before enrollment. 4) Measurable disease according to RECIST v1.1 criteria 5) ECOG performance status 0 or 1 6) Age 19 years or older 7) Adequate cardiac function 8) Adequate bone marrow, hepatic, and renal function Hematology - Neutrophil ? 1,500/mm3 - Platelet ? 100,000/mm3 - Hemoglobin ? 9 g/dL Liver function tests - Total bilirubin = 1.5 xULN - AST, ALT = 3 xULN (in case of liver metastasis, 5 x upper limit of normal) Renal function tests - Creatinine clearance ? 30 mL/min 9) Life expectancy more than 3 months 10) Signed and dated informed consent of document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment 11) Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion criteria

Exclusion criteria: 1) ??>65? 2) RECIST v1.1? ?? ????? ??? 1??? ?? ??? ??? ??? ?? ??. ??? ??? ?? ?? ???? ????? ?????, ??? ??? ??? ??? ????. 3) ???? ?? ????? ?? (??? ???/?? ???? ??) 4) 2?? ??? ?????? 5) ?? 2? ?? ?? ????? ???? ??. ?, ??? ??? ?? ? ????? ?? ???????, ???? ????, ???? ? 4?? ??? ????? ??? ??? ???. 6) ?? ?? ?? ???? ?? ?? ?? ??? ?? ?? ?? 6?? ?? ??? ??? ??? ?? ?? 7) ??? ??? ????, ?? ???? ???, ???? ?? 8) ???? ?? 9) ????? ??? ??? ?? ????(?????, ??????, ???) 10) ???? ??? ?? ????? ?? ?? 11) ?? ??? ???? ??? ????? ????? ?? ?? (5-5 ??) 12) ??????, ?????, 5-FU ? ???? ? ?? ?? ??

Design outcomes

Primary

Measure	Time frame
Objective response rate	—

Secondary

Measure	Time frame
Safety, Progression-free survival (PFS), Overall survival (OS), Incidence of febrile neutropenia	—

Countries

Korea, Republic of

Contacts

Public ContactMaria Kim

Asan Medical Center

Outcome results