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

Sponsor

Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) (Other)

Overall Status

Completed

CT.gov ID

NCT00202774

Collaborator

(none)

348

Enrollment

Location

Duration (Months)

7.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Drug: (capecitabine, oxaliplatin, 5-fluorouracil)	Phase 3

Detailed Description

Study Design

Study Type:

Interventional

Actual Enrollment :

348 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2002

Actual Primary Completion Date :

Aug 1, 2004

Actual Study Completion Date :

Dec 1, 2005

Outcome Measures

Primary Outcome Measures

Determine time to disease progression []

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Spanish Cooperative Group for Gastrointestinal Tumour Therapy (TTD)	Madrid		Spain	28046

Sponsors and Collaborators

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)