New chemo timing aims to cut harsh side effects for GI cancer patients
NCT ID NCT06648785
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a modified way of giving two chemotherapy drugs (capecitabine and oxaliplatin) to people with gastrointestinal cancers. The goal is to see if the new schedule causes fewer side effects, like nerve damage and low blood counts, compared to standard treatments. About 20 adults whose cancer is not curable but who need treatment for at least three months will take part. The study focuses on safety and how well patients tolerate the new schedule.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient with GI malignancy * Provider plans non-curative intent treatment with either CAPOX or FOLFOX (mFOLFOX6) at standard dosages for \>3 months NOTE: Patient is not required to have radiologically measurable disease. NOTE: Planned administration of other anti-cancer medications (eg bevacizumab, epidermal growth factor receptor antibodies, immunotherapy, tyrosine kinase inhibitors) is allowed. Exclusion Criteria: * Patients not meeting standard hematologic parameters for chemotherapy administration as follows: * Absolute neutrophil count (ANC) ≥ 1500 * Platelet count ≥ 100,000 Patients not meeting standard liver function parameters for chemotherapy administration as follows: * AST ≤ 5x ULN * ALT ≤ 5X ULN * Total Bilirubin ≤ 1.5X ULN Patients not meeting standard renal function parameters for chemotherapy administration as follows: * Serum Creatinine ≤ 1.2 or creatinine clearance ≥ 30 ml/min NOTE: Planned administration of another cytotoxic chemotherapy (eg irinotecan) is an exclusion.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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
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University of Vermont
Burlington, Vermont, 05401, United States
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University of Vermont Medical Center
Burlington, Vermont, 05401, United States
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