Study of Target-Guided Chemotherapy in Metastatic Colorectal Patients (TT)
A Phase 2 Study of Target-Guided Personalized Chemotherapy in Metastatic Colorectal Cancer Patients
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%.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Madrid, Spain, 28050
- Centro Integral Oncologico Clara Campal
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Chemotherapy treatment
Tailored chemotherapy by Therapeutic Targets
|
Patients will be treated with Folfox, Folfiri, Xelox or Xeliri and Cetuximab or Bevacizumab at usual doses tailored by: K-ras native: Cetuximab. K-ras mutated: Bevacizumab Topoisomera 1 positive ( Topo-1): Irinotecan Topo-1 positive and ERCC-1 negative: oxaliplatin Topo-1 1 negative and ERCC-1 positive: investigator option Thimidylate synthase (TS) positive: No Fluoropyrimidines (FLP) TS negative: FLP Thimidylate phosphorylasa (TP) positive: Capecitabine TP negative: 5-FU
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
PFS
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Complete Response Rate
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Antonio Cubillo, Md PhD, Grupo Hospital madrid
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C62 202-878
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