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Addition of Antibiotics to Upfront Treatment Regimen for Colorectal Cancer

NCT06728072 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2026-05-06

No results posted yet for this study

Summary

This is a 2-arm, noncomparative phase 2 trial designed to evaluate treatment outcomes with or without the addition of ciprofloxacin, metronidazole, and aspirin to first-line chemotherapy for patients with stage IV colorectal cancer (CRC).

Conditions

Interventions

DRUG

Standard of Care Chemotherapy + Metronidazole, ciprofloxacin, aspirin

Metronidazole, ciprofloxacin, aspirin is initiated Cycle 1 Day 1 of chemotherapy. May be initiated any time from 7 days before Cycle 1 Day 1 up to and including Cycle 1 Day 3

Sponsors & Collaborators

  • American Cancer Society, Inc.

    collaborator OTHER

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Emily Kinsey, MD · Virginia Commonwealth University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-07
Primary Completion
2035-07-01
Completion
2035-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT06728072 on ClinicalTrials.gov