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

NCT ID: NCT03504618

Last Updated: 2018-04-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 39 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2018-02-01

Brief Summary

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

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"

Conditions

Colorectal Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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

FOLFOXIRI

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hanoi Medical University

OTHER

Sponsor Role: lead

Responsible Party

Bui My Hanh

Director, Science Research and International Cooperation Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hanoi Medical University

Hanoi, , Vietnam

Countries

Vietnam

Other Identifiers

HMU16223

Identifier Type: -

Identifier Source: org_study_id