Ignite Creation Date:
2024-05-06 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 12:52 PM
Study NCT ID:
NCT03641976
Status:
UNKNOWN
Last Update Posted:
2020-10-19
First Post:
2018-08-20
Brief Title:
A Study of Bevacizumab Infusional Fluorouracil Leucovorin Oxaliplatin and Irinotecan A-FOLFOXIRI Compared With Bevacizumab Infusional Fluorouracil Leucovorin and IrinotecanOxaliplatin A-FOLFIRIFOLFOX as First-line Treatment for Metastatic Right-sided Colon Cancer
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
A Randomized Open-label Multicenter Phase II Study of Bevacizumab Infusional Fluorouracil Leucovorin Oxaliplatin and Irinotecan A-FOLFOXIRI Compared With Bevacizumab Infusional Fluorouracil Leucovorin and IrinotecanOxaliplatin A-FOLFIRIFOLFOX as First-line Treatment for Metastatic Right-sided Colon Cancer
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
RECRUITING
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:
RATIONALE Recently the importance of prognosis according to the location of the primary tumor in colorectal cancer has been raised In the CALGB SWOG 80405 study published in 2016 the addition of bevacizumab or cetuximab to the first line FOLFIRI FOLFOX in KRAS codon 12 13 wild type metastatic colorectal cancer mCRC patients did not show a significant difference between overall survival OS and progression free survival PFS in both groups Alan P Venook et al published a follow-up subgroup analysis on the effect of primary tumor location at 2016 ASCO In the treatment group with cetuximab the difference in treatment effect was significant according to the primary tumor location The right colon cancer showed a poor prognosis for cetuximab treatment PFS 78 vs 124 months HR 156 p 00001 OS 167 vs 360months HR 187 P 00001
Therefore the investigators propose a phase II trial for the efficacy evaluation of bevacizumab-FOLFOXIRI and bevacizumab-FOLFIRI or FOLFOX treatment in patients with poor prognosis of unresectable right-sided colorectal cancer
Therefore the investigators propose a phase II trial for the efficacy evaluation of bevacizumab-FOLFOXIRI and bevacizumab-FOLFIRI or FOLFOX treatment in patients with poor prognosis of unresectable right-sided colorectal cancer
Detailed Description:
OUTLINE This is a multicenter study Patients are stratified according to ECOG performance status 0 vs 1-2 prior adjuvant chemotherapy yes vs no and participating center Patients are randomized to 1 of 2 treatment arms
Arm I A-FOLFOXIRI Patients receive irinotecan hydrochloride IV over 1 hour oxaliplatin IV over 2 hours leucovorin calcium IV over 2 hours and bevacizumab IV on day 1 Patients also receive fluorouracil IV continuously over 48 hours beginning on day 1
Arm II A-FOLFOXFOLFIRI Patients receive irinotecan hydrochloride IV over 1 hour or oxaliplatin IV over 2 hours leucovorin calcium IV over 2 hours fluorouracil IV bolus and bevacizumab IV on day 1 Patients also receive fluorouracil IV continuously over 48 hours beginning on day 1
In both arms treatment repeats every 2 weeks for up to 12 courses After the 12 cycle treatment finished investigator decides whether to keep the study drug Treatment continues in the absence of disease progression withdrawal consent or unacceptable toxicity If treatment with oxaliplatin or irinotecan is difficult due to side effects treatment with bevacizumab fluorouracil and leucovorin calcium continues in the absence of disease progression withdrawal consent or unacceptable toxicity
Patients undergo serum extraction and blood sample collection periodically for genomic ctDNA and translational study Patients also undergo collection of tumoral sections from paraffin embedded primary andor metastatic lesions periodically for immunohistochemical analyses
After completion of study treatment patients are followed every 6 months for survival and other treatments
Arm I A-FOLFOXIRI Patients receive irinotecan hydrochloride IV over 1 hour oxaliplatin IV over 2 hours leucovorin calcium IV over 2 hours and bevacizumab IV on day 1 Patients also receive fluorouracil IV continuously over 48 hours beginning on day 1
Arm II A-FOLFOXFOLFIRI Patients receive irinotecan hydrochloride IV over 1 hour or oxaliplatin IV over 2 hours leucovorin calcium IV over 2 hours fluorouracil IV bolus and bevacizumab IV on day 1 Patients also receive fluorouracil IV continuously over 48 hours beginning on day 1
In both arms treatment repeats every 2 weeks for up to 12 courses After the 12 cycle treatment finished investigator decides whether to keep the study drug Treatment continues in the absence of disease progression withdrawal consent or unacceptable toxicity If treatment with oxaliplatin or irinotecan is difficult due to side effects treatment with bevacizumab fluorouracil and leucovorin calcium continues in the absence of disease progression withdrawal consent or unacceptable toxicity
Patients undergo serum extraction and blood sample collection periodically for genomic ctDNA and translational study Patients also undergo collection of tumoral sections from paraffin embedded primary andor metastatic lesions periodically for immunohistochemical analyses
After completion of study treatment patients are followed every 6 months for survival and other treatments
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