Efficacy and Safety Study of a Modified XELOX Regimen in First-Line Treatment of Metastatic Colorectal Adenocarcinoma

Study Overview
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Brief Summary
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This is an open-label, phase II study to evaluate the efficacy and safety of a modified regimen of oxaliplatin and capecitabine on metastatic colorectal adenocarcinoma in the first-line therapy.

Detailed Description
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Primary endpoint: Overall Response Rate Secondary endpoint: Time to progression, overall survival, safety data

Official Title
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A Phase II Trial Evaluating a Modified Regimen of Oxaliplatin and Capecitabine in First-Line Treatment of Metastatic Colorectal Adenocarcinoma

Conditions
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Colorectal Adenocarcinoma

Intervention / Treatment
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* Drug: Capecitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed written informed consent; Patients with histologically or cytologically confirmed stage IV colorectal adenocarcinoma whose ECOG performance status are 0-2; Presence of measurable disease by radiographic study (including CT or MRI scan, or chest x-ray) or physical examination; At least 3 weeks since last major surgery; At least 12 months since last adjuvant chemotherapy; At least 6 weeks since prior radiotherapy providing that the extent and site of radiotherapy fields are such that marked bone marrow suppression is NOT expected; Patients who have received palliative radiotherapy must have recovered from any reversible toxic effects e.g. nausea and vomiting caused by radiation of fields; Patients with reproductive potential must use effective BC; Required Screening Laboratory Criteria: Hemoglobin 90g/L WBC 3.5 x 109/L Neutrophils 1.5 x 109/L Platelets 100 x 109/L Creatinine 133 umol/L and creatinine clearance 60 mL/min A probable life expectancy of at least 6 months; Exclusion Criteria: Brain metastases; Female of childbearing potential, pregnancy test is positive; Concomitant malignancies or previous malignancies other than colorectal cancer within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or low grade prostate cancer; Active infection; Concurrent severe medical problems unrelated to the malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk; Sexually active patients refusing to practice adequate contraception; Patients with conditions which might affect absorption of an oral drug (for example intermittent obstruction) unless discussed and agreed with principal investigator; History of grade 3 or 4 toxicity to fluoropyrimidines; Pre-existing neuropathy ≥ NCI CTC grade 2.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Capecitabine|Oxaliplatin 85mg/m2 D1 and capecitabine 1g/m2 BID D1-D10, repeat every two weeks. Efficacy will be evaluated every three cycles.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate according to RECIST 1.1 |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression |  | One year | 
| overall survival |  | One Year | 
| Safety data of this regimen |  | One Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal cancer, Adenocarcinoma, XELOX