drugset / Trial / NCT03015675

IV Ascorbic Acid in Advanced Gastric Cancer

NCT03015675

Phase 3 Unknown 200 enrolled Sun Yat-sen University
RandomizedParallel-groupOpen-labelTreatment

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 Apc/KRASG12D mutant mice. Previous phaseⅠclinical trials have found that high dose (1.5g/kg or 90g/m2) 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.

Timeline

Start
2017-03-12
Primary completion
2017-12
Completion
2019-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Vitamin C Other / unclassified 20 g Intravenous
Background Leucovorin Small molecule 400 mg/m2
Background Oxaliplatin Small molecule 85 mg/m2
Background fluorouracil Small molecule 2400 mg/m2

Indications