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2 Versus 6 Hour Oxaliplatin Infusions in Patients With Gastrointestinal Cancers

NCT03800693 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-11-06

No results posted yet for this study

Summary

This phase II trial studies how well giving oxaliplatin over 6 hours works in treating nerve damage in patients with gastrointestinal cancers. Oxaliplatin can cause side effects such as nerve damage that may delay or reduce the dose of oxaliplatin. Giving oxaliplatin over a longer period of time (6 hours) may prevent or delay the development of nerve damage, which may keep patients on standard doses of chemotherapy longer, without having to delay treatment.

Conditions

  • Malignant Digestive System Neoplasm

Interventions

DRUG

Fluorouracil

Given IV

DRUG

Leucovorin

Given IV

DRUG

Oxaliplatin

Given IV

Sponsors & Collaborators

  • Hematology/Oncology Pharmacy Association

    collaborator UNKNOWN

  • University of Pittsburgh

    collaborator OTHER

  • Emory University

    lead OTHER

Principal Investigators

  • Olumide B. Gbolahan, MBBS, MSc · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-14
Primary Completion
2026-08-05
Completion
2026-09-17
FDA Drug
Yes

Countries

  • United States

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 NCT03800693 on ClinicalTrials.gov