Study of Target-Guided Chemotherapy in Metastatic Colorectal Patients

Phase 2

Completed

• Conditions: Progression Free Survival
• Interventions: Drug: Tailored Chemotherapy

• Registration Number: NCT01453257
• Lead Sponsor: Grupo Hospital de Madrid

Brief Summary

Treatment options for patients with colorectal cancer (CRC) have increased in the last years. However, there are no validated prospective molecular markers in CRC to select which agents are better to treat any individual case. The conventional first-line treatment in CRC patients in clinical studies get a proportion of patients free of progression at 12 months ranging from 35-40% with a median of 9 months of free disease progression.

The aim of this study is to demonstrate that the identification of therapeutic targets in real time and their prospectively use to customize the treatment get a proportion of colorectal metastatic patients patients free of progression disease at 12 months of 50%.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Status Verified: 2011-10
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Study First Submitted: 2011-10-13
• Study First Submitted QC: 2011-10-14
• Study First Posted: 2011-10-17
• Last Update Submitted: 2011-10-18
• Last Update Posted: 2011-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Colorectal adenocarcinoma stage IV patients.
• ECOG= 0-1
• Age > 18 years.
• Fit to receive chemotherapy treatment
• Availability of tumor tissue or possibility of a tumor biopsy to determine therapeutic targets.
• Adequate renal (Cr < 1,5 mg/d), liver (bilirubin≤1,5 mg/dl, AST and ALT ≤ 3.0 x the upper limit of normal) and normal bone marrow function ( absolute neutrophil count ≥ 1500/µl, hemoglobin ≥ 9.0g/dl and a platelet count of ≥ 100.000/µl)

Exclusion Criteria

• Contraindication for the administration of any of the drugs used in the study including capecitabine, irinotecan, oxaliplatin, cetuximab or bevacizumab.
• Previous Chemotherapy treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chemotherapy treatment	Tailored Chemotherapy	Tailored chemotherapy by Therapeutic Targets

Primary Outcome Measures

Name	Time	Method
PFS	12 months

Secondary Outcome Measures

Name	Time	Method
Complete Response Rate	12 months

Trial Locations

Locations (1)

Centro Integral Oncológico Clara campal; 🇪🇸 Madrid, Spain