Ignite Creation Date:
2024-05-06 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 2:19 PM
Study NCT ID:
NCT05148767
Status:
RECRUITING
Last Update Posted:
2021-12-08
First Post:
2021-10-07
Brief Title:
UGT1A1-Based Irinotecan Therapy for Locally Advanced Rectal Cancer
Sponsor:
Zhejiang Cancer Hospital
Organization:
Zhejiang Cancer Hospital
Study Overview
Official Title:
Neoadjuvant Chemoradiation With Irinotecan Guided by UGT1A1 Status in Patients With Locally Advanced Rectal Cancer A Real-Word Multi-center Study
Status:
RECRUITING
Status Verified Date:
2021-12
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:
None
Brief Summary:
To explore whether the application of irinotecan under the guidance of UGT1A1 gene in neoadjuvant chemotherapy and radiotherapy for locally advanced rectal cancer could improve the clinical efficacy in the real world
Detailed Description:
Neoadjuvant chemoradiotherapy nCRT combined with surgery is the standard care of treatment for locally advanced rectal cancer LARC which could effectively reduce the risk of local recurrence increase the chance of sphincter preservation and effectively improve the quality of life of patients However only about 8 of patients can benefit from nCRT Therefore to improve the therapeutic effect of nCRT and retain the organ function of patients so as to improve their quality of life is the focus of the current investigation
In the previous study the investigator have completed a series of clinical researches of irinotecan guided by UGT1A1 gene for nCRT in rectal cancer A dose climbing study was firstly conducted to explore the maximum tolerable dose of irinotecan for nCRT in rectal cancer The results indicated that the weekly dose intensity of irinotecan could be increased from 50mgm2 to 80mgm2 when the genotype of UGT1A128 locus was 66 and the weekly dose intensity of irinotecan could also reach 65mgm2 when the genotype of irinotecan was 67 phenotype Further analysis also demonstrated that there was a dose-effect relationship between the total dose of irinotecan and pathological complete remission pCR The recently published CinClare study is a 3-phase randomized controlled trial that doubles the pCR rate and the total CR rate in combination with irinotecan on the basis of capecitabine combined with radiotherapy However in the Aristotle study conducted in the United Kingdom at the same phase it has not been proved that irinotecan could improve the pCR rate and it is not known whether the difference between the two studies is completely attributed to the irinotecan dose Therefore the investigator designed this real-world study to explore whether irinotecan can indeed improve the treatment efficacy in the real world when using irinotecan under the guidance of UGT1A1 gene in nCRT for LARC Any locally advanced rectal cancer patients treated with irinotecan-based neoadjuvant radiotherapy and chemotherapy can be enrolled in this study It is expected that the results of this study could provide more basis for individualized treatment of LARC
In the previous study the investigator have completed a series of clinical researches of irinotecan guided by UGT1A1 gene for nCRT in rectal cancer A dose climbing study was firstly conducted to explore the maximum tolerable dose of irinotecan for nCRT in rectal cancer The results indicated that the weekly dose intensity of irinotecan could be increased from 50mgm2 to 80mgm2 when the genotype of UGT1A128 locus was 66 and the weekly dose intensity of irinotecan could also reach 65mgm2 when the genotype of irinotecan was 67 phenotype Further analysis also demonstrated that there was a dose-effect relationship between the total dose of irinotecan and pathological complete remission pCR The recently published CinClare study is a 3-phase randomized controlled trial that doubles the pCR rate and the total CR rate in combination with irinotecan on the basis of capecitabine combined with radiotherapy However in the Aristotle study conducted in the United Kingdom at the same phase it has not been proved that irinotecan could improve the pCR rate and it is not known whether the difference between the two studies is completely attributed to the irinotecan dose Therefore the investigator designed this real-world study to explore whether irinotecan can indeed improve the treatment efficacy in the real world when using irinotecan under the guidance of UGT1A1 gene in nCRT for LARC Any locally advanced rectal cancer patients treated with irinotecan-based neoadjuvant radiotherapy and chemotherapy can be enrolled in this study It is expected that the results of this study could provide more basis for individualized treatment of LARC
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?:
False
Is an FDA AA801 Violation?:
None