Skip to main content
OpenTrials
Completed

NCT Number: NCT03504618

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hanoi Medical University

Hanoi, 10000, Vietnam

About this study

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"

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FOLFOXIRI

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

Primary outcomes

  1. Patients' characteristic

    Time frame: 4 years

    Clinico-pathology features of metastatic colon cancer patients whose disease was not radically resectable

  2. Response rate after 3 cycles

    Time frame: At the end of Cycle 3 (each cycle is 4 weeks)

    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.

  3. Response rate after 6 cycles

    Time frame: At the end of Cycle 6 (each cycle is 4 weeks)

    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.

  4. Correlation between response rate and percentage of chemotherapy dosage

    Time frame: 4 years

    Prognostic factor of response rate

  5. Correlation between response rate and histopathology

    Time frame: 4 year

    Prognostic factor of response rate

  6. Correlation between response rate and metastatic site

    Time frame: 4 years

    The average size of the hepatic metastatic lesion in the study

  7. Prognostic factor for response rate after 3 cycles

    Time frame: At the end of cycle 3 (each cycle is 4 weeks)

    Evaluation of predictor of response rate

  8. Prognostic factor for response rate after 6 cycles

    Time frame: At the end of cycle 6 (each cycle is 4 weeks)

    Evaluation of predictor of response rate

  9. Mean of the progression free survival

    Time frame: 4 years

    The median progression free survival of the study population

  10. Prognostic factor of progression free survival

    Time frame: 4 years

    Evaluation of predictor of progression free survival

Secondary outcomes

  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: 4 years

    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.

  2. Overall survival after 12 months

    Time frame: 12 months after the last patient finish chemotherapy

    The percentage of survival patients 12 month after finishing treatment with FOLFOXIRI regimen

  3. Overall survival after 24 months

    Time frame: 24 months after the last patient finish chemotherapy

    The percentage of survival patients 24 month after finishing treatment with FOLFOXIRI regimen

Sponsors and collaborators

Lead sponsor

Hanoi Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Apr 20, 2018
Registry last updated
Apr 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.