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Algorithm for cytopenia-related delay and dose-reduction of mFOLFOX chemotherapy for Colorectal Cancer

N/A
Waitlist Available
Led By Gabriel A Brooks, MD
Research Sponsored by Dartmouth-Hitchcock Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The treating oncologist's recommendation must be for six or more cycles of standard-dose mFOLFOX chemotherapy (with or without concurrent bevacizumab, cetuximab, panitumumab, or trastuzumab). Intent of treatment may be either curative or palliative in nature.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up single chemotherapy treatment visit on day 1 of cycle 3, 4, or 5 (cycle length is 14 days)
Awards & highlights

Study Summary

This trial is testing whether a new chemotherapy dosing method can reduce delays in treatment while still being effective.

Eligible Conditions
  • Colorectal Cancer
  • Stomach Cancer
  • Esophageal Cancer
  • Ampullary Cancer
  • Small Bowel Cancer
  • Appendiceal Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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The doctor recommends a chemotherapy treatment called mFOLFOX for at least six cycles, either with or without other drugs like bevacizumab or cetuximab. The purpose of the treatment can be to cure or to relieve symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~single chemotherapy treatment visit on day 1 of cycle 3, 4, or 5 (cycle length is 14 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and single chemotherapy treatment visit on day 1 of cycle 3, 4, or 5 (cycle length is 14 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Unplanned chemotherapy treatment delay
Secondary outcome measures
Composite safety endpoint
Out of pocket costs associated with chemotherapy treatment visits
Relative dose intensity of chemotherapy

Trial Design

1Treatment groups
Experimental Treatment
Group I: Study ArmExperimental Treatment1 Intervention
All patients in this single-arm study will be exposed to the experimental chemotherapy dose-adjustment algorithm.

Find a Location

Who is running the clinical trial?

Dartmouth-Hitchcock Medical CenterLead Sponsor
524 Previous Clinical Trials
2,543,287 Total Patients Enrolled
Gabriel A Brooks, MDPrincipal InvestigatorDartmouth-Hitchcock Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open enrollment opportunities for this research initiative?

"According to the information posted on clinicaltrials.gov, this research study is open for recruitment and was initially listed on October 15th 2020 with a recent update made in November 3rd 2022."

Answered by AI

What is the upper bound of enrollees in this medical experiment?

"Affirmative. The clinicaltrials.gov database reveals that this medical trial, originally posted on October 15th 2020, is still recruiting participants. In total, 50 individuals need to be enrolled from 1 center."

Answered by AI
~12 spots leftby Apr 2025