Evidence map›Paper›PMID 39961593›Full record

Trial reportCancer research and treatment2026

A Multicenter Phase II Study of Modified FOLFIRINOX for First-Line Treatment for Advanced Urachal Cancer (ULTIMA; KCSG GU20-03).

Inkeun Park, Jae Lyun Lee, Shinkyo Yoon, Sang Joon Shin, Seong-Hoon Shin, Jung Hoon Kim, Kwonoh Park, Hyo Jin Lee

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer research and treatment, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04611724 (A Multicenter Prospective Phase II Study of Modified FOLFIRINOX for 1st Line Treatment for Advanced Urachus Cancer), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04611724 phase2unknown statusnot on this map

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

TypeinterventionalSponsorAsan Medical CenterRan2020 to 2024Enrolled35ConditionsUrachal CancerArmsFOLFIRINOX
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Inkeun ParkDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Jae Lyun LeeDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Shinkyo YoonDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Sang Joon ShinDivision of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea.
Seong-Hoon ShinDepartment of Internal Medicine, Kosin University Gospel Hospital, Busan, Korea.
Jung Hoon KimDivision of Medical Oncology and Hematology, Department of Internal Medicine, Pusan National University Yangsan Hospital, Yangsan, Korea.
Kwonoh ParkDivision of Medical Oncology and Hematology, Department of Internal Medicine, Pusan National University Yangsan Hospital, Yangsan, Korea.
Hyo Jin LeeDepartment of Internal Medicine, Chungnam National University Hospital, Daejeon, Korea.

Funding

PROVIDE RABBITS, RATS MICE, HAMSTERS GERBILS, GUINEA PIGS27307C0012 · NIEHS · PI BOLEN, WAYNE · 2007 to 2007
$1.0M
Korean Cancer Study GroupMinistry of Health and Welfare HA22C0012National Cancer CenterNIEHS NIH HHS 27307C0012
6 · The paper itself

Abstract

purposeThis study aimed to assess the efficacy and safety of first-line modified FOLFIRINOX in patients with advanced urachal cancer. MATERIALS AND

methodsThe ULTIMA trial (NCT04611724) is a single-arm, open-label, multicenter phase II study evaluating modified FOLFIRINOX (oxaliplatin 85 mg/m2 over 2 hours, irinotecan 150 mg/m2 over 1.5 hours, leucovorin 400 mg/m2 over 2 hours, and 5-fluorouracil 2,400 mg/m2 over 46 hours) plus prophylactic pegteograstim in patients with recurrent or metastatic urachal cancer every 2 weeks for up to 12 cycles, or until disease progression or unacceptable toxicity. The primary endpoint was the overall response rate (ORR). Secondary endpoints included progression-free survival (PFS), overall survival (OS), and the incidence of febrile neutropenia.

resultsBetween April 2021 and November 2023, 21 patients with advanced urachal cancer were enrolled across five cancer centers. The median age was 50 years (range, 28 to 68 years), with 15 male patients. The most common metastatic site was the lung (47.6%), followed by lymph nodes (38.1%) and peritoneal seeding (33.3%). Two patients and 11 patients achieved a complete and partial response, respectively, yielding an ORR of 61.9%. The study met its primary endpoint in the first stage. With a median follow-up of 23.3 months, the median PFS was 9.3 months (95% confidence interval [CI], 6.7 to 11.9), and the median OS was 19.7 months (95% CI, 14.3 to 25.1). The treatment regimen was well tolerated, with no unexpected adverse events, and no instances of febrile neutropenia or grade 4 adverse events.

conclusionIn this preliminary analysis of the ULTIMA trial, Modified FOLFIRINOX demonstrated a promising ORR and PFS in patients with advanced urachal cancer. Completing the full study is essential to confirm the potential role of this regimen in the management of advanced urachal cancer.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsUrinary Bladder NeoplasmsAdultAgedFemaleFluorouracilHumansIrinotecanLeucovorinMaleMiddle AgedOxaliplatinFluorouracilfolfirinoxIrinotecanLeucovorinOxaliplatin5-FluorouracilIrinotecanOxaliplatinUrachal cancer

Identifiers

PMID39961593
PMCPMC12800932

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.