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Enrolling by invitation NCT06648785

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

Phase II Interventional GI Cancers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: oxaliplatin, Fluoropyrimidine.
Who it may be relevant to
Registry conditions: GI Cancers. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug oxaliplatin
    85 mg/m2 oxaliplatin
  • Drug Fluoropyrimidine
    oral fluoropyrimidine 1000mg/m2

Primary outcome measures

  • Tolerability [Time frame: 115 days]
  • Toxicity [Time frame: 115 days]
  • Neuropathy [Time frame: 2-4 months after therapy]
  • Cytopenias [Time frame: 115 days]
Secondary outcome measures (1)
  • Tumor response [Time frame: 115 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • University of Vermont Medical Center — Burlington
  • University of Vermont — Burlington

Identifiers

NCT: NCT06648785 · STUDY00003100/UVMCC2404

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗