Ignite Creation Date:
2024-07-17 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06475352
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-20
Brief Title:
Dose Individualization of Chemotherapy in Patients With Gastrointestinal Cancers Lacking a Specific Liver Enzyme
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
Dihydropyrimidine Dehydrogenase DPD Phenotype-guided Dose Individualization of Fluoropyrimidine-based Chemotherapy in DPD Deficient Patients With Gastrointestinal Cancers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FUDOSE
Brief Summary:
The goal of this clinical trial is to establish guidelines for fluoropyrimidine dose reduction according to uracilemia in patients with DPD deficiency in the treatment of digestive cancers The main question it aims to answer is
- Which reduction dose of fluoropyrimidine is needed for patient with DPD deficiency
Participants will
Take the treatment with the reduction of dose stated by the protocol
Visit the clinic once every 2-3 weeks for checkups and tests for collection of adverse events
- Which reduction dose of fluoropyrimidine is needed for patient with DPD deficiency
Participants will
Take the treatment with the reduction of dose stated by the protocol
Visit the clinic once every 2-3 weeks for checkups and tests for collection of adverse events
Detailed Description:
Multicenter phase II trial evaluating different strategies of pre-specified fluoropyrimidine-dose adjustment according to U in DPD-deficient patients with gastrointestinal cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-509963-25-00 | CTIS | None | None |