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Vitamin C Intravenously With Chemotherapy in Advanced Colorectal Cancer

NCT02969681 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 442

Last updated 2023-06-27

No results posted yet for this study

Summary

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 aslo impairs tumor growth in Apc/KRASG12D mutant mice. Previous phase Ⅰ studies have found that high dose iv AA is well tolerated in cancer patients.This protocol is a phase Ⅲ study of AA infusions combined with treatment with FOLFOX +/- bevacizumab versus treatment with FOLFOX +/- bevacizumab alone as first-line therapy in patients with recurrent or advanced colorectal cancer.

Conditions

  • Colorectal Neoplasms

Interventions

DRUG

ascorbic acid

1.5g/kg/day, D1-3, every 2 weeks

DRUG

Chemotherapy

* mFOLFOX6 * Oxaliplatin 85 mg/m² d1 concurrent with * Leucovorin 400 mg/m², followed by * Bolus 5FU 400 mg/m² , followed by * Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks with or without bevacizumab 5mg/kg, every 2 weeks

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Rui-hua Xu, MD.,PhD. · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2020-12-30
Completion
2020-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02969681 on ClinicalTrials.gov