Exploratory Study in Achievement of Improved Survival by Molecular Targeted Chemotherapy and Liver Resection for Not Optimally Resectable Colorectal Liver Metastases

Colorectal Cancer Clinical Trial

— ATOM ES  

Official title:

An Exploratory Study to Evaluate Biomarkers as Predictive and /or Prognostic Factors of Benefit From Randomized Phase ll Study of mFOLFOX6+Bevacizumab or mFOLFOX6+Cetuximab in Liver Only Metastasis From KRAS Wild Type Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01834014
• Other study ID #: ATOM Exploratory study
• Secondary ID: UMIN000010429
• Status: Completed
• Phase: N/A
• First received: April 14, 2013
• Last updated: August 1, 2017
• Start date: May 2013
• Est. completion date: March 2017

Study information

• Verified date: August 2017
• Source: EPS Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The correlation between the values of angiogenesis-related growth factors in plasma and efficacy, and biomarkers relevant as prognostic factors or predictive factors for sensitivity or resistance to treatment will be examined exploratively.

Description:

The correlation between the values of angiogenesis-related growth factors in plasma and efficacy, and biomarkers relevant as prognostic factors or predictive factors for sensitivity or resistance to treatment will be examined exploratively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients who registered the ATOM trial and signed informed consent prior to initiation of any trial-specific procedure and treatment.

Exclusion Criteria:

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Liver Metastasis
• Liver Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

Drug:
• Bevacizumab
5 mg/kg intravenously administered over 90 minutes (can be reduced to 30 minutes at the minimum) on day 1 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.
• Cetuximab
250 mg/m2 intravenously administered over 60 minutes (400 mg/m2 over 120 minutes as the initial dose) on day 1 and day 8 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.
• L-OHP
85 mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.
• l-LV
200 mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.
• 5-FU
400 mg/m2 intravenous bolus on day 1 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.
• 5-FU
2400 mg/m2 continuous infusion over 46 hours on day 1 and 2 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.

Locations

Country	Name	City	State
Japan	EPS Corporation	Shinjuku-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
EPS Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the values of angiogenesis-related growth factors in plasma with Progression-free survival (PFS)	To evaluate the values of angiogenesis-related growth factors in plasma with PFS centrally assessed	Baseline, Cycle 8, Progression Disease
Secondary	To evaluate the correlation of values of angiogenesis-related growth factors in plasma with efficacy and adverse events	Response rate, Tumor shrinkage rate, Liver resection rate, R0 liver resection rate( pathologically confirmed ), Progression-free survival(CT/MRI image assessed by the attending physician), Time to treatment-failure, Overall survival, Incidence of adverse events (drag-related, surgery-related) , Exploratory endpoints	Baseline, Cycle 8, Progression Disease
Secondary	Progression-free survival among the RAS wild type subpopulation		assessed every 8 weeks, up to 4 years
Secondary	Exploratory analysis of the relevance of tumor size and expression level of angiogenesis-related growth factors in plasma		Baseline, Cycle 8, Progression Disease