Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06648785

Modified Capecitabine and Oxaliplatin (mCAPOX) for Patients With GI Malignancies

This study is a single arm, non-randomized feasibility study with tolerability and toxicity evaluation as primary endpoints which seeks to determine if a modified administration schedule of capecitabine with oxaliplatin will result in less toxicity than standard FOLFOX or CAPOX regimens.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

GI Cancers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Vermont, Burlington, Vermont, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxaliplatin

Drug

85 mg/m2 oxaliplatin

fluoropyrimidine

Drug

oral fluoropyrimidine 1000mg/m2

Primary outcomes

  1. Tolerability

    Time frame: 115 days

    Number of toxicity-related treatment delays Number of dose reductions

  2. Toxicity

    Time frame: 115 days

    Severity of acute oxaliplatin reactions, graded 1-4

  3. Neuropathy

    Time frame: 2-4 months after therapy

    Neuropathy will be graded 1-4 after 2 &4 months of severity

  4. Cytopenias

    Time frame: 115 days

    Frequency of cytopenia grade 3 or higher.

Secondary outcomes

  1. Tumor response

    Time frame: 115 days

    Response rate after 3-4 months, with exact time of restaging per investigator choice and investigator usual practice

Sponsors and collaborators

Lead sponsor

University of Vermont Medical Center

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 18, 2024
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.