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

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

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Brief 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.

Study ID ULTIMA NCT04611724
Fase Phase 2
Enrollment 35
Study type Interventional
Has expanded access -

Locations

Korea, Republic of
  • Asan Medical Center, Seoul, Korea, Republic of
    Recruiting

Design info

N/A Single Group Assignment Treatment None (Open Label)

Drug

Condition

Eligibility

Criteria

  • Gender: all
  • Age: 19 - 65
  • Healthy volunteers: no
  • Therapy type: -
  • Therapy Specification: -

Contact information

Local contact information

Overall contact

  • Lastname overall: Jae -Lyun Lee, Professor
  • Role: Principal Investigator
  • Affiliation: Asan Medical Center
  • NordicNect: No
Verification date 2020-10-01
Study first submitted 2020-10-26
Study first posted 2020-11-02
Last update submitted 2020-10-29
Last update posted 2020-11-02

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