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

Phase 2

• Conditions: Colorectal Adenocarcinoma

• Registration Number: NCT01552967
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Brief Summary

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

Primary endpoint: Overall Response Rate

Secondary endpoint: Time to progression, overall survival, safety data

Study Timeline

• Status Verified: 2012-03
• Study Start: 2012-03
• Study First Submitted: 2012-03-05
• Study First Submitted QC: 2012-03-09
• Study First Posted: 2012-03-13
• Last Update Submitted: 2012-03-27
• Last Update Posted: 2012-03-28
• Primary Completion: 2013-08
• Study Completion: 2014-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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;

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Overall response rate according to RECIST 1.1	One year

Secondary Outcome Measures

Name	Time	Method
Time to progression	One year
overall survival	One Year
Safety data of this regimen	One Year

Trial Locations

Locations (1)

the Sixth Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China