Research on the Treatment of Metastatic Colon Cancer Patients Treated by FOLFOXIRI

Research on the Treatment of Metastatic Colon Cancer Patients Treated by FOLFOXIRI Regimen (Folinic Acid, 5-fluorouracil, Oxaliplatin and Irinotecan)

Colon cancer with metastase in the diagnose time account for one significant rate and has a increasing trend. The treatment result of this patient group rests modest. The biological therapeutic treatment is still expensive for major part of Vietnamese patients. So that, research on a new affordable and efficacious chemotherapy combination for these patients is extremely necessary in our country The purpose of the study is to comment somes clinico-pathology features of metastatic colon cancer patients whose disease was not radically resectable.

The second aim is to Evaluate the treatment result and toxicity of FOLFOXIRI in these patients

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: FOLFOXIRI

Detailed Description

In the world, colorectal cancer is the third most common cancer in male and the second most common cancer in female. In VietNam, the disease is the fourth cancer in male, the sixth cancer in female and increasing recently. About 20-40% of the colon cancer patients had distant metastasis at the time of diagnose, those treatment outcome remains poor (5years survival is about 11%). The targetted therapy medications are still not affordable for majority of Vietnamese patients. So that, 3 cytotoxic drugs (5-Fluoro-Uracil, Oxaliplatin and Irinotecan) remain back-bone in the treatment of metastatic colon cancer.

According to one meta-analysis, the overall survival rate significantly correlated to the use of all 3 these drugs in the treatment time. If patients were give two drugs as the doublet in a line (FOLFOX/XELOX, FOLFIRI/XELIRI), not 100% of patients are treated with all 3 these drugs because some abandonned the following treatment lines. So, the trials that give all 3 drugs in a line (first-line) as triplet (FOLFOXIRI) were carried out and had primirily good outcome. In 2010, FOLFOXIRI were recommended in NCCN guideline.

In VietNam, FOLFOXIRI has been applied to treat patient since 2013. However, since then there was no clinical trial to evaluate the efficacy and the toxicity of this combination. Therefore, we carried out the work "Research on the treatment of metastatic colon cancer patients treated by FOLFOXIRI"

• Study Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

• Vietnam
  • Hanoi, Vietnam, 10000
    • Hanoi Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients recruited to the study will be explained in detail will be required to sign a volunteer card. All detailed information on the patient's medical condition is encrypted and confidential. The patient has the right to withdraw from the study

Description

Inclusion Criteria:

• 39 colon cancer patients with metastase at the diagnotic time, impossiblity of radical resection, adenocarcinoma, treated by at least 3 cylces of FOLFOXIRI in the first-line in the Oncology and Palliative Care Department, Ha Noi medical university hospital, from September 2013 to April 2017

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Metastatic colon cancer patients; Colon cancer patients with metastase at the diagnostic time, impossibility of radical resection, adenocarcinoma, treated by at least 3 cycles of FOLFOXIRI in the first-line in the Oncology and Palliative Care Department

Drug: FOLFOXIRI; Treatment of FOLFOXIRI regimen at first line with dosage: Irinotecan: 165 mg / m2, intravenous infusion for 1 hour. Day 1, 15. Oxaliplatin: 85 mg / m2, intravenously for 2 hours Day 1, 15 Calcium folinate 200 mg / m2, intravenously for 2 hours Day 1, 15 5FU 3200 mg / m 2, intravenous infusion continuously for 48 hours Day 1, 2, 3, 15, 16, 17 Every 4 weeks. Each cycle has 2 infusion times, the first one is the first day, the second one is the 15th day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' characteristic	Clinico-pathology features of metastatic colon cancer patients whose disease was not radically resectable	4 years
Response rate after 3 cycles	Responses are evaluated according to WHO criteria. The determination of responses and progression was initially based on investigator-reported measurements; computed tomography scans of all responding patients and of patients with stable disease were subsequently subjected to external review by an independent panel.	At the end of Cycle 3 (each cycle is 4 weeks)
Response rate after 6 cycles	Responses are evaluated according to WHO criteria. The determination of responses and progression was initially based on investigator-reported measurements; computed tomography scans of all responding patients and of patients with stable disease were subsequently subjected to external review by an independent panel.	At the end of Cycle 6 (each cycle is 4 weeks)
Correlation between response rate and percentage of chemotherapy dosage	Prognostic factor of response rate	4 years
Correlation between response rate and histopathology	Prognostic factor of response rate	4 year
Correlation between response rate and metastatic site	The average size of the hepatic metastatic lesion in the study	4 years
Prognostic factor for response rate after 3 cycles	Evaluation of predictor of response rate	At the end of cycle 3 (each cycle is 4 weeks)
Prognostic factor for response rate after 6 cycles	Evaluation of predictor of response rate	At the end of cycle 6 (each cycle is 4 weeks)
Mean of the progression free survival	The median progression free survival of the study population	4 years
Prognostic factor of progression free survival	Evaluation of predictor of progression free survival	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	During the full length of first-line treatment, number of enrolled patients reporting adverse events is recorded. Adverse events are evaluated according to National Cancer Institute Common Toxicity Criteria latest version.	4 years
Overall survival after 12 months	The percentage of survival patients 12 month after finishing treatment with FOLFOXIRI regimen	12 months after the last patient finish chemotherapy
Overall survival after 24 months	The percentage of survival patients 24 month after finishing treatment with FOLFOXIRI regimen	24 months after the last patient finish chemotherapy

Collaborators and Investigators

• Sponsor: Hanoi Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: April 4, 2018
• First Submitted That Met QC Criteria: April 12, 2018
• First Posted (Actual): April 20, 2018

Study Record Updates

• Last Update Posted (Actual): April 20, 2018
• Last Update Submitted That Met QC Criteria: April 12, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: HMU16223

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No