Urachal CancerPhase 2NCT04611724
A Multicenter Prospective Phase II Study of Modified FOLFIRINOX for 1st Line Treatment for Advanced Urachus Cancer
A Phase 2 study testing FOLFIRINOX in people with Urachal Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Urachal Cancer
- What is being tested?
- FOLFIRINOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2020to 30 Sep 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Patients with locally advanced, recurrent, or metastatic disease not amenable to surgery, 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 is allowed if it ended more than 6 months before enrollment.
- Measurable disease according to RECIST v1.1 criteria
- ECOG performance status 0 or 1
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- 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 legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Who cannot join
- Age > 65
- Previous radiotherapy to the only measurable lesion: but previous radiotherapy will be permitted 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 for adequately treated basal cell or squamous cell carcinoma of skin, or in situ carcinoma of cervix uteri or prostate cancer and curatively treated thyroid cancer of any stage.
- Pregnancy or breast feeding, or intention of becoming pregnant during study treatment or within 6 months after final dose
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- Other severe acute or chronic medical or psychiatric condition
- Chronic diarrhea
- Clinically significant cardiac disease (heart failure, coronary artery disease, and/or arrhythmia)
- Hypersensitivity to study medication
- treatment with a prohibited medication or anticipation of need for prohibited medication ( section 5.5 )
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul
Jae-Lyun Lee, Professor
About this study
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
- Being tested
- FOLFIRINOX
- Keywords
- Urachal Cancer, FOLFIRINOX
- Medical subject headings
- Urachal cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFIRINOXDrug
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
| Study group | Role | What they receive |
|---|---|---|
| FOLFIRINOX | Experimental | 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 Receives: Drug: FOLFIRINOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Objective response rate
Measured: up to 2 years
Secondary outcomes (4)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: every 2 weeks up to 30 weeks.
Progression-free survival (PFS)
Progression-free survival (PFS)
Measured: up to 2years.
Overall survival (OS),
Overall survival (OS),
Measured: up to 5 years.
Incidence of febrile neutropenia
Incidence of febrile neutropenia
Measured: After study completion (an average of 2 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start1 Dec 2020 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urachal CancerStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Green Cross Corporation, Boryung Pharmaceutical Co., Ltd
- Responsible party
- Principal investigator, Jae-Lyun Lee, Asan Medical Center
- Investigators
- Jae -Lyun Lee, Professor, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611724
- Sponsor's protocol ID
- ULTIMA
- Status last verified
- Oct 2020
- First submitted
- 26 Oct 2020
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozaka M, Ishii H, Sato T, Ueno M, Ikeda M, Uesugi K, Sata N, Miyashita K, Mizuno N, Tsuji K, Okusaka T, Furuse J. A phase II study of modified FOLFIRINOX for chemotherapy-naive patients with metastatic pancreatic cancer. Cancer Chemother Pharmacol. 2018 Jun;81(6):1017-1023. doi: 10.1007/s00280-018-3577-9. Epub 2018 Apr 9.
PubMed 29633005Kume H, Tomita K, Takahashi S, Fukutani K. Irinotecan as a new agent for urachal cancer. Urol Int. 2006;76(3):281-2. doi: 10.1159/000091635.
PubMed 16601395
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Phase II Study of Modified FOLFIRINOX for 1st Line Treatment for Advanced Urachus Cancer
- ClinicalTrials.gov ID
- NCT04611724
- Acronym / sponsor ID
- ULTIMA
- Conditions
- Urachal Cancer
- Keywords
- Urachal Cancer, FOLFIRINOX
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Green Cross Corporation, Boryung Pharmaceutical Co., Ltd
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 2 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FOLFIRINOX | Experimental | Drug: FOLFIRINOXoxaliplatin 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 |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
- Patients with locally advanced, recurrent, or metastatic disease not amenable to surgery, 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 is allowed if it ended more than 6 months before enrollment.
- Measurable disease according to RECIST v1.1 criteria
Key exclusion criteria (11 listed)
- Age > 65
- Previous radiotherapy to the only measurable lesion: but previous radiotherapy will be permitted 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 for adequately treated basal cell or squamous cell carcinoma of skin, or in situ carcinoma of cervix uteri or prostate cancer and curatively treated thyroid cancer of any stage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FOLFIRINOXoxaliplatin 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 | Drug | FOLFIRINOX |
Primary outcome
Objective response rate
Time frame: up to 2 years
Objective response rate
4 secondary outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: every 2 weeks up to 30 weeks.
Progression-free survival (PFS)
Time frame: up to 2years.
Overall survival (OS),
Time frame: up to 5 years.
Incidence of febrile neutropenia
Time frame: After study completion (an average of 2 year)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Background: PubMed 29633005Ozaka M, Ishii H, Sato T, Ueno M, Ikeda M, Uesugi K, Sata N, Miyashita K, Mizuno N, Tsuji K, Okusaka T, Furuse J. A phase II study of modified FOLFIRINOX for chemotherapy-naive patients with metastatic pancreatic cancer. Cancer Chemother Pharmacol. 2018 Jun;81(6):1017-1023. doi: 10.1007/s00280-018-3577-9. Epub 2018 Apr 9.
- Background: PubMed 16601395Kume H, Tomita K, Takahashi S, Fukutani K. Irinotecan as a new agent for urachal cancer. Urol Int. 2006;76(3):281-2. doi: 10.1159/000091635.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jae -Lyun Lee, Professor principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FOLFIRINOX in people with Urachal Cancer, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jae -Lyun Lee, Professor (82 2 3010 5977, jaelyun@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04611724, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2020.