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Gene test could make chemo safer by tailoring doses

NCT ID NCT07158164

Disease control Sponsor: Rutgers, The State University of New Jersey Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adjusting the dose of chemotherapy drugs (fluorouracil or capecitabine) based on a person's DPYD gene test can lower the risk of severe side effects. About 100 cancer patients with a specific gene variant will receive either a reduced starting dose or standard dose. The goal is to find a safer, more personalized way to give chemotherapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Fluorouracil or Capecitabine (chemotherapy drugs)
What this could lead to
If successful, this could make chemotherapy safer by using a genetic test to personalize doses, reducing severe side effects without lowering effectiveness.
What could go wrong
This is a small, early-phase study (100 people) and results may not apply to all patients. The genetic test is not yet standard, and dose adjustments might still lead to side effects or reduced cancer control.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of cancer in either the adjuvant or metastatic setting requiring initial therapy with 5-FU or Capecitabine. * DPYD testing performed by a CLIA-certified laboratory (i.e., Guardant 360 or Caris blood testing for genomic profiling, DPYD testing by the Mayo Clinic or other certified laboratory) with results available before starting chemotherapy. * DPYD testing results falling into one of the following cohorts for first-line therapy with a fluoropyridine: * Study Cohort: Patients with one DPYD variant in one gene (heterozygotes). * Control Arm: Patients with normal or wild-type DPYD genes, for comparison, will be treated at the usual 100% dose. --FOLFOX regimen (N=50) * ECOG Performance Status 0-2. * Measurable disease or non-measurable disease allowed, including adjuvant 5-FU-based regimens. Exclusion Criteria: * Patients for whom 5-FU or Capecitabine therapy is contraindicated or not deemed appropriate in the judgment of the treating physician. * Patients with two DPYD variants (homozygous deletions or non-functional genetic variants, or double heterozygotes with two different abnormalities) should not receive 5-FU or Capecitabine and are therefore excluded from the study. * Pregnant Women and Children

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Conditions

The condition(s) this trial relates to.

breast neoplasm colorectal neoplasm head and neck neoplasm Head and Neck Neoplasms small intestinal intraepithelial neoplasia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast neoplasms Colorectal neoplasms Gastro-intestinal intraepithelial neoplasia Head and neck neoplasms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cancer Center Initiative

    RECRUITING

    Newark, New Jersey, 07103, United States

  • Cooperman Barnabas Medical Center

    RECRUITING

    Livingston, New Jersey, 07039, United States

  • Jack and Sheryl Morris Cancer Center

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • RWJBarnabas Health - Community Medical Center

    RECRUITING

    Toms River, New Jersey, 08755, United States

  • RWJBarnabas Health - Robert Wood Johnson University Hospita

    RECRUITING

    New Brunswick, New Jersey, 08903, United States

  • RWJBarnabas Health - Robert Wood Johnson University Hospital Somerset

    RECRUITING

    Somerville, New Jersey, 08873, United States

  • RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton

    RECRUITING

    Hamilton, New Jersey, 08690, United States

  • RWJBarnabas Health Clara Maas Medical Center

    RECRUITING

    Belleville, New Jersey, 07109, United States

  • RWJBarnabas Health Jersey City Medical Center

    RECRUITING

    Jersey City, New Jersey, 07302, United States

  • RWJBarnabas Health Newark Beth Israel Medical Center

    RECRUITING

    Newark, New Jersey, 07112, United States

  • Trinitas Hospital and Comprehensive Cancer Center

    RECRUITING

    Elizabeth, New Jersey, 07202, United States

  • University Hospital

    RECRUITING

    Newark, New Jersey, 07103, United States

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