Ignite Creation Date:
2024-05-06 @ 9:34 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03015675
Status:
UNKNOWN
Last Update Posted:
2017-05-18
First Post:
2017-01-08
Brief Title:
IV Ascorbic Acid in Advanced Gastric Cancer
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Phase Ⅲ Study of IV Ascorbic Acid in Combination With XELOX vs Treatment With XELOX Alone as First-line Therapy for Advanced Gastric Cancer
Status:
UNKNOWN
Status Verified Date:
2017-03
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:
Linus Pauling and Dr Ewan Cameron have published two retrospective studies about using high dose vitamin C to treat cancer patients forty years ago Their studies have shown that high dose vitamin C usage could significantly prolong overall survival of patients with advanced cancer Recently preclinical study has shown that human colorectal cancer cells harboring KRAS or BRAF mutations are selectively killed by high levels of ascorbic acid AA High dose of AA impairs tumor growth in ApcKRASG12D mutant mice Previous phaseⅠclinical trials have found that high dose 15gkg or 90gm2 iv AA is well tolerated in cancer patients This protocol is a phase Ⅲ study of ascorbic acid AA infusions combined with treatment with mFOLOX6 versus mFOLOX6 alone as first-line therapy in patients with recurrent or advanced gastric cancer
Detailed Description:
Linus Pauling and Dr Ewan Cameron have published two retrospective studies about using high dose vitamin C to treat cancer patients forty years ago Their studies have shown that high dose vitamin C usage could significantly prolong overall survival of patients with advanced cancer Recently preclinical study has shown that human colorectal cancer cells harboring KRAS or BRAF mutations are selectively killed by high levels of ascorbic acid AA High dose of AA impairs tumor growth in ApcKRASG12D mutant mice Previous phaseⅠclinical trials have found that high dose 15gkg or 90gm2 iv AA is well tolerated in cancer patients This protocol is a phase Ⅲ study of ascorbic acid AA infusions combined with treatment with mFOLOX6 versus mFOLOX6 alone as first-line therapy in patients with recurrent or advanced gastric 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?:
False
Is an FDA AA801 Violation?:
None