Safety and Efficacy Study of XELOX vs. Oxaliplatin+5-FU CI as First Line Treatment in Metastatic Colorectal Cancer

Phase III, Multicenter, Ramdomised, Open-label, Study to Evaluate the Safety and Efficacy of Combination Therapy With XELOX vs. Oxaliplatin and 5-FU CI as First Line Treatment in Advanced or Metastatic Colorectal Cancer

The purpose of this study is to determine time to disease progression of combination therapy with capecitabine and oxaliplatin (XELOX) vs. oxaliplatin and 5-fluorouracil in continous infusion (5-FU CI) as first line treatment in advanced or metastatic colorectal cancer

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: (capecitabine, oxaliplatin, 5-fluorouracil)

Detailed Description

The purpose of this study is to determine time to disease progression of combination therapy with capecitabine and oxaliplatin (XELOX) vs. oxaliplatin and 5-fluorouracil in continous infusion (5-FU CI) as first line treatment in advanced or metastatic colorectal cancer

• Study Type: Interventional
• Enrollment (Actual): 348
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28046
    • Spanish Cooperative Group for Gastrointestinal Tumour Therapy (TTD)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Written informed consent. Men and women > or = 18 years Karnofsky functional status >or=70% at the time of enrollment in study Histologically confirmed diagnosis of CRC Patients must not have received chemotherapy (exception: adjuvant treatment > 12 months following conclusion of treatment) Presence of at least one lesion detectable by two-dimensional measurement.. Life expectancy greater than 3 months.

Exclusion Criteria:

Pregnant or nursing woman Prior administration of systemic immunotherapy, chemotherapy (exception: 5-FU as adjuvant treatment > 12 months following conclusion of treatment) Evidence of allergic reaction to any of the treatment components Clinically relevant myocardial disease or history of myocardial infarction in the past 12 months Documented or suspected cerebral and/or leptomeningeal metastases. Prior malignant tumour in past 5 years, except history of basal cell skin carcinoma or pre-invasive cervical carcinoma.

Neutrophil count < 1.5 x 109/l , platelets < 100 X 109/l serum creatinine > 1.5 x ULN. Total bilirubin count > 2 x ULN Alkaline Phosphatase > > 2.5 x ULN (> 5 x ULN if there are hepatic metastases) Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) > 2.5 x ULN (> 5 x ULN if there are hepatic metastases, > 10 x ULN if there are bone metastases) Creatinine clearance < 30 ml/min Surgery within 4 weeks prior to enrollment in the study. Any investigational drug during the 4 weeks prior to enrolment. Uncontrolled active infection Any medical or psychological disorder which, in the opinion of the investigator, does not allow the patient to conclude the study or sign the informed consent

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Determine time to disease progression

Secondary Outcome Measures

Outcome Measure
Determine safety of combination, objetive response rate, time to onset of response , duration of response, time to treatment failure, one year survival time, overall survival time

Collaborators and Investigators

• Sponsor: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
• Investigators: Study Chair: Enrique Aranda, Spanish Cooperative Group for Gastrointestinal Tumour Therapy (TTD); Study Chair: Eduardo Díaz-Rubio, Spanish Cooperative Group for Gastrointestinal Tumour Therapy (TTD)

Study record dates

Study Major Dates

• Study Start: April 1, 2002
• Primary Completion (Actual): August 1, 2004
• Study Completion (Actual): December 1, 2005

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 20, 2005

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: colorectal cancer, capecitabine, oxaliplatin, 5-fluorouracil
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Fluorouracil; Capecitabine; Oxaliplatin
• Other Study ID Numbers: 03-TTD-01