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

NCT04611724 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2020-11-02

No results posted yet for this study

Summary

This study aims to assess objective response rate of modified FOLFIRINOX in advanced urachaus cancer.

Patients with locally advanced, recurrent, or metastatic urachal carcinoma of bladder, urachal will be enrolled this study.

Modified version of FOLFIRINOX(Oxaliplatin 85 mg/m 2, Leucovorin 400mg/m2 , irinotecan 150mg/m2 and 5-FU 2400mg/m2) with prophylactic pegateograstim will be continued till progression, unacceptable toxicity, or till 12 cycles (24 weeks). Study drugs can be administered after 12 cycles to the subjects with benefit from study medication.

Response evaluation will be done every 6 weeks.

Conditions

  • Urachal Cancer

Interventions

DRUG

FOLFIRINOX

oxaliplatin 85 mg/m2 IV over 2 hours leucovorin 400 mg/m2 over 2 hours irinotecan 150 mg/m2 over 90 min, 5-FU continuous infusion 2400 mg/m2 continuous infusion over 46 hours

Sponsors & Collaborators

  • Green Cross Corporation

    collaborator INDUSTRY

  • Boryung Pharmaceutical Co., Ltd

    collaborator INDUSTRY

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Jae -Lyun Lee, Professor · Asan Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2023-12-31
Completion
2024-09-30
FDA Drug
Yes

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04611724 on ClinicalTrials.gov